“RISK FACTOR ANALYSIS FOR NEONATAL SEPSIS AND THE OUTCOME IN TERTIARY CARE

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“RISK FACTOR ANALYSIS FOR NEONATAL SEPSIS AND THE OUTCOME IN TERTIARY CARE

NEONATAL NURSERY ”

Dissertation Submitted to

THE TAMIL NADU DR.M.G.R.MEDICAL UNIVERSITY CHENNAI

In partial fulfillment of the regulations for the award of the degree of

M.D. BRANCH – VII (PAEDIATRICS)

INSTITUTE OF SOCIAL PAEDIATRICS STANLEY MEDICAL COLLEGE, CHENNAI.

THE TAMIL NADU DR.M.G.R.MEDICALUNIVERSITY

TAMILNADU, INDIA

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CERTIFICATE BY GUIDE

This is to certify that this dissertation entitled “RISK FACTOR ANALYSIS FOR NEONATAL SEPSIS AND THE OUTCOME IN TERTIARY CARE NEONATAL NURSERY” submitted by Dr.B.JANE AMALA SEBASTY to the faculty of PAEDIATRICS, The Tamil Nadu Dr. M.G.R Medical University, Chennai, Tamilnadu, in partial fulfillment of the requirement for the award of M.D DEGREE BRANCH-VII (PAEDIATRICS) is a bonafide research work carried out by her under my direct supervision and guidance.

GUIDE

Prof.Dr.M.Jayakumar M.D.,DCH., Professor of Paediatrics,

Institute of Social Paediatrics,

Stanley Medical College and Hospital, Chennai 1.

Place : Date :

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CERTIFICATE BY THE INSTITUTION

This is to certify that this dissertation entitled “RISK FACTOR ANALYSIS FOR NEONATAL SEPSIS AND THE OUTCOME IN TERTIARY CARE NEONATAL NURSERY” submitted by Dr.B.JANE AMALA SEBASTY to the faculty of PAEDIATRICS, The Tamil Nadu Dr.M.G.R Medical University, Chennai, Tamilnadu, in partial fulfillment of the requirement for the award of M.D DEGREE BRANCH-VII (PAEDIATRICS) is a bonafide research work carried out by her under my direct supervision and guidance.

Dr.T.Ravichandran, M.D., DCH., Director,

Institute of Social Paediatrics, Stanley Medical College and Hospital, Chennai-1

Dr.R.Shanthimalar, M.D., DA., Dean,

Stanley Medical College andHospital, Chennai-1

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DECLARATION

I, Dr.B.JANE AMALA SEBASTY, solemnly declare that Dissertation titled “RISK FACTOR ANALYSIS FOR NEONATAL SEPSIS AND THE OUTCOME IN TERTIARY CARE NEONATAL NURSERY” is a bonafide work done by me at Government Stanley Hospital Chennai, during June 2018 to May 2019 under the guidance and supervision of Prof.Dr.M.Jayakumar, Professor of Paediatrics, Institute of Social Paediatrics, Stanley Medical College and Hospital, Chennai. I also declare that this bonafide work or a part of this work was not submitted by me or any other for award degree or diploma to any other university, board either in India or abroad.

This dissertation is submitted to the Tamilnadu DR.M.G.R Medical University, towards the partial fulfillment of requirement for the award of M.D. Degree Branch – VII in PAEDIATRICS.

Signature of the candidate Place: Chennai

Date:

(Dr.B.Jane Amala Sebasty)

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SPECIAL ACKNOWLEDGEMENT

I gratefully acknowledge and thank PROF.Dr.R.SHANTHIMALAR M.D.,DA.

DEAN

STANLEY MEDICAL COLLEGE AND HOSPITAL, CHENNAI.

For granting me permission to utilize the resources of this Institution for my study.

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CERTIFICATE - II

This is to certify that this dissertation work titled “RISK FACTOR ANALYSIS FOR NEONATAL SEPSIS AND THE OUTCOME IN TERTIARY CARE NEONATAL NURSERY” of Dr.B.Jane Amala Sebasty, the candidate with Registration Number 201717051 for the award of M.D., DEGREE in the branch of BRANCH-VII PAEDIATRICS. I personally verified the urkund.com website for the purpose of plagiarism Check. I found that the uploaded thesis file contains from introduction to conclusion pages and result shows 10 percentage of plagiarism in the dissertation.

Guide & Supervisor sign with Seal

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ACKNOWLEDGEMENT

I am extremely thankful to our beloved Superintendent Prof.Dr.DHANASEKAR, M.D., Government Stanley Hospital Chennai- 1, for having granted permission to do this dissertation in Government Stanley Hospital, Chennai.

I am also extremely thankful to our beloved Superintendent Prof.Dr.Kalaivani M.D., Govt. RSRM Lying in Hospital, Chennai-1, for having granted permission to do this dissertation in Govt. RSRM Lying in Hospital, Chennai.

I am very grateful to our Professor and Director, Institute of Social Paediatrics Prof.Dr.T.Ravichandran M.D.,DCH., for the acceptance to do this dissertation.

I am extremely grateful to my Chief Prof Dr.M.Jayakumar M.D., DCH., who taught me the basic aspects and clinical skills in Paediatrics which is an essential pre requisite for pursuing any dissertation work.

The guidance and encouragement they provided need a special mention I recall with gratitude the other unit chiefs of Department of Paediatrics, Prof.Dr.M.A.Aravind M.D., Prof.Dr.J.Ganesh M.D., DCH., Prof.Dr.Mekalai Sureshkumar MD.,DCH., Prof.Dr.V.Poovahaghi

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MD., Prof. Dr.Senthilkumar MD., and Prof. Dr.Senthilkumar MD., for their valuable guidance.

I am extremely thankful to our Registrar Dr.T.S.Ekambaranath M.D., and Asst. Professor SNCU, ISP Dr.S.Rajeshkumar M.D. and RSRM Lying in Hospital NICU Asst. Professor Dr.Shanthi M.D and Dr.Kabilan M.D for their guidance.

I am extremely grateful to our unit Asst. Professor Dr.P.Venkatesh M.D., Dr.M.Vinoth M.D., Dr.M.Sankaranarayanan M.D., Dr.P.Parveenkumar M.D., Dr.J.Senthilkumar M.D., Dr.A.Selvi M.D, DCH., Dr.P.Anandhi M.D., DCH., for their valuable suggestions, guidance and support.

I thank Prof.Dr.ARUNA LATHA, M.D. Head of the Department, Dept. of Pathology, Government Stanley Hospital for helping me in interpreting complete blood count in the thesis work which was very crucial for the study.

I thank Prof.Dr.SARAVANAN M.D., Head of the department, Department of Biochemistry for providing me with facilities for accurate measurement of the biochemical parameters involved in the thesis work which was very crucial for the study.

I thank Prof.Dr.DILLIRANI, M.D., Head of the department, Department of Microbiology, Government Stanley Hospital for helping

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me with blood culture in my thesis work which was important for my study.

I also thank our little babies and their parents without whom the study would not be possible.

I extend my love and gratitude to my family and friends for their immense help for this study.

I owe my thanks to almighty for successful completion of this study.

Signature of the candidate Place: Chennai

Date:

(Dr.B.Jane Amala Sebasty)

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ABBREVIATIONS

NICU : Neonatal Intensive Care Unit SNCU : Special Neonatal Care Unit NNF : National Neonatal Forum

NNPD : National Neonatal Perinatal Database SDG : Sustainable Developmental Goals EOS : Early Onset Sepsis

LOS : Late Onset Sepsis TLC : Total Leukocyte Count ANC : Absolute Neutrophil Count CRP : C Reactive Protein

ESR : Erythrocyte Sedimentation Rate CSF : Cerebrospinal Fluid

NEC : Necrotizing Enterocolitis

DIVC : Disseminated Intravascular Coagulopathy PIH : Pregnancy Induced Hypertension

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GDM : Gestational Diabetes Mellitus PROM : Premature Rupture of Membranes MSAF : Meconium Stained Amniotic Fluid SGA : Small for Gestational Age

AGA : Appropriate for Gestaional Age LGA : Large for Gestational Age

LBW : Low Birth Weight

VLBW : Very Low Birth Weight

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LIST OF TABLES

S.

No. TITLE PAGENO.

1 RISK FACTORS INCLUDED IN META ANALYSIS 2 RISK FACTORS INCLUDED IN META ANALYSIS 3 RISK FACTOR FOR EARLY ONSET SEPSIS

4 PERINATAL RISK FACTORS

5 RISK FACTORS FOR COMMUNITY ACQUIRED AND NOSOCOMIAL INFECTIONS

6 RISK FACTORS FOR NEONATAL SEPSIS 7 CORRELATION OF RISK FACTORS WITH

CULTURE POSITIVE SEPSIS

8 RISK FACTORS OF LATE ONSET SEPSIS 9 TOOL FOR SEPSIS SCREENING

10 DIAGNOSTIC ACCURACY OF MICRO ESR

11 DIAGNOSTIC ACCURACY OF

HAEMATOLOGICAL PARAMETERS 12 CSF FINDINGS IN NEWBORN

13 DURATION OF ANTIBIOTICS IN SEPSIS 14 EMPIRICAL CHOICE OF ANTIBIOTICS 15 OUTLINE OF THE RESULTS

16 MATERNAL RISK FACTORS IN INTRAMURAL SEPSIS

17 NATAL RISK FACTORS IN INTRAMURAL SEPSIS 18 NEONATAL RISK FACTORS IN INTRAMURAL

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S.

19 MATERNAL RISK FACTORS –EOS IN INTRAMURAL SEPSIS

20 NATAL RISK FACTORS FOR EOS IN INTRAMURAL SEPSIS

21 NEONATAL RISK FACTORS- EOS IN INTRAMURAL SEPSIS

22 MATERNAL RISK FACTORS –LOS IN INTRAMURAL SEPSIS

23 NATAL RISK FACTORS –LOS IN INTRAMURAL SEPSIS

24 NEONATAL RISK FACTORS –LOS IN INTRAMURAL SEPSIS

25 ASSOCIATION OF MODE OF DELIVERY WITH SEPSIS

26 ASSOCIATION OF BIRTH ASPHYXIA AND SEPSIS

27 ASSOCIATION OF CORD HYGIENE WITH SEPSIS 28 ASSOCIATION OF BAD CRP WITH SEPSIS

29 ASSOCIATION OF MATERNAL FEVER WITH OUTCOME

30 ASSOCIATION OF PROM WITH OUTCOME 31 ASSOCIATION OF LIQUOR WITH OUTCOME 32 ASSOCIATION OF MATURITY WITH OUTCOME 33 ASSOCIATION OF MODE OF DELIVERY WITH

SEPSIS

34 ASSOCIATION OF BIRTH ASPHYXIA AND SEPSIS

35 ASSOCIATION OF CORD HYGIENE WITH SEPSIS 36 ASSOCIATION OF BAD CRP WITH SEPSIS

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S.

37 NATAL RISK FACTORS IN EXTRAMURAL SEPSIS 38 NEONATAL RISK FACTORS IN EXTRAMURAL

SEPSIS

39 ASSOCIATION OF PLACE OF DELIVERY IN EXTRAMURAL SEPSIS

40

ASSOCIATION OF MODE OF DELIVERY IN EXTRAMURAL SEPSIS

41 ASSOCIATION OF CORD HYGIENE IN EXTRAMURAL SEPSIS

42 ASSOCIATION OF BAD CRP IN EXTRAMURAL SEPSIS

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LIST OF FIGURES

S.

No TITLE PAGE

No.

1 MOUZINHO CHART 2 MANROE’S CHART

3 SEX DISTRIBUTION IN INTRAMURAL NEONATES 4 GRAVIDA DISTRIBUTION IN INTRAMURAL

NEONATES

5 BIRTH WEIGHT DISTRIBUTION IN INTRAMURAL SEPSIS

6 WEIGHT FOR GESTATIONAL AGE 7 MATURITY

8 BIRTH ASPHYXIA IN INTRAMURAL SEPSIS 9 BLOOD CULTURE IN INTRAMURAL SEPSIS

10 ORGANISMS GROWN IN CULTURE IN INTRAMURAL SEPSIS

11 OUTCOME IN INTRAMURAL SEPSIS

12 SEX DISTRIBUTION-EOS IN INTRAMURAL SEPSIS 13 BIRTH WEIGHT DISTRIBUTION- EOS IN

INTRAMURAL SEPSIS

14 WEIGHT FOR GESTATIONAL AGE

15 MATURITY- EOS IN INTRAMURAL SEPSIS

16 BLOOD CULTURE - EOS IN INTRAMURAL SEPSIS 17 OUTCOME-EOS IN INTRAMURAL SEPSIS

18 SEX DISTRIBUTION- LOS IN INTRAMURAL SEPSIS 19 BIRTH WEIGHT DISTRIBUTION-LOS IN

INTRAMURAL SEPSIS

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S.

No TITLE PAGE

No.

22 BLOOD CULTURE - LOS IN INTRAMURAL SEPSIS 23 OUTCOME OF LOS IN INTRAMURAL SEPSIS

24 SEX DISTRIBUTION IN EXTRAMURAL SEPSIS 25 BIRTH WEIGHT DISTRIBUTION IN EXTRAMURAL

SEPSIS

28 BIRTH ASPHYXIA IN EXTRAMURAL SEPSIS 29 BLOOD CULTURE IN EXTRAMURAL SEPSIS 30 OUTCOME OF EXTRAMURAL SEPSIS

31 ORGANISMS GROWN IN CULTURE IN EXTRAMURAL SEPSIS

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INTRODUCTION

New born period is the beginning of life. This provides the foundation for future health of the nation. Under-five mortality is the major concern in our country. In the Under-five mortality, the most vulnerable population is the neonatal period (0-28 days of life), accounting for more than half of under-five child deaths^1,2. According to NNPD 2002 -2003 incidence of neonatal sepsis is 30/1000 live birth³. Sustainable Developmental Goals provide a new strategy to reduce neonatal mortalities. SDG 3 aims to reduce neonatal mortality to as low as 12 deaths per 1000 live births by 2030. The World Health Organization Essential Newborn Care guidelines are evidence based measures that can be used to meet SDG 3⁴. They encompass breastfeeding, cord care, eye care, thermoregulation, management of asphyxia, recognition of danger signs, immunization and care of the low birth weight infant. This requires active participation of health care professionals and mother in providing essential newborn care.

Sepsis is the second most common cause of mortality, next to prematurity. The highest incidence of clinical sepsis (17%)⁵ occurs throughout India. The Neonatal sepsis includes pneumonia, meningitis, septicemia, urinary tract infection, arthritis and osteomyelitis⁶. Among all the neonatal sepsis, 25 to 40 % have culture positivity⁶. In the developing country like India, with the resource limited setting and the

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delay in obtaining culture positivity report (upto 48 hrs), combination of risk factors and clinical signs aid in treatment^6,8,9. Hence, I pursued this study to analyse the risk factors causing neonatal sepsis and thereby helps in avoidance of risk factors, early diagnosis of neonatal sepsis and its management.

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AIM AND OBJECTIVES OF THE STUDY

PRIMARY OBJECTIVE:

To study the risk factors for neonatal sepsis admitted in NICU.

SECONDARY OBJECTIVE:

To study the association of risk factors with culture positivity and mortality.

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REVIEW OF LITERATURE

Shruti Murthy et al¹⁰ had done a systematic review and meta analysis on the risk factors for neonatal sepsis with fifteen studies and the analysis results showed following as the emerging risk factors:

Table-1: Risk Factors included in Meta Analysis

Odds Ratio 95%

Confidence Interval

Male sex 1.3 1.02, 1.68

Premature rupture of membranes 11.14 5.54, 22.38

Artificial ventilation 5.61 8.21, 41.18

Out born newborns 5.5 2.39, 12.49

Prematurity <37weeks 2.05 1.40, 2.99

Table -2

Perera et al¹¹ studied the Risk factors for early neonatal sepsis in the term baby. This retrospective case control study was conducted in Sri Jayewardenepura General Hospital (SJGH) and observed the results as follows: 15% had PROM, 35% had labour room stay of 9 hours or

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more, 21% had induced labour, 3.7% had maternal fever and 1.8% had foul smelling liquor.

The study showed the statistical significance for the following risk factors:

Table-3: Risk Factor For Early Onset Sepsis

Risk Factors p Value 95% Confidence Interval PROM >18 hours <0.0001 9.0417 to 21.4687

Labour room stay >9 hours <0.0001 12.1647 to 32.0328 3 or more vaginal examinations <0.0001 18.4781 to 41.6906

Maternal fever, Induced labour, High vaginal swab positivity for GBS and foul smelling liquor had no statistical significance with the p value 0.30,0.34,0.14 and 0.14 respectively with 95% confidence interval.

Mamtha jajoo et al¹² studied the Incidence and Risk Factors in the Out born neonates with early onset sepsis. This study was conducted at Maulana Azad Medical College, New Delhi. Sepsis screen was positive (≥2 factors present) in 46 (56%) neonates and negative in 36 (43%) neonates. Out of total screen positive neonates, only 10 (17%) were blood culture positive and among the septic screen negative (36) neonates, only 5 (11%) had blood culture proven sepsis. Incidence of early onset sepsis in this study was 18/1000 live births.

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Table-4: Perinatal Risk Factors

Risk factor (n=82) Number (%)

Low birth weight 56 (68.3)

Maternal fever 16 (19.5)

Foul smell/meconium stained liquor 18 (22)

PROM >24 hours 46 (56)

>3 vaginal examinations 29 (35.4)

Perinatal asphyxia 29 (35.4)

Untrained dai 26 (31.7)

Poor hygiene/cord care 38 (46.3)

Most common organisms were Klebsiella pneumonia 5 (36%), Staphylococcus aureus 3 (21%), and Escherichia coli 2 (14%). The sensitivity pattern observed were sensitive to meropenam 80%, piperacillin-tazobactum (75%), cefotaxime (50%), imipenem (50%) and chloramphenicol (50%).

The highest mortality rate of 62.5% was observed in neonates with respiratory distress . 50% of newborns with septic shock succumbed to death. Preterm neonates (8%) had higher mortality rate when compared to term neonates.

Sunit Pathak et al¹³ studied the risk factors and bacterial etiology

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retrospective study was conducted in Sarojini Naidu Medical College, Agra among 182 neonates. This study compared the risk factors and its association with the community acquired and hospital acquired infections.

Table-5: Risk Factors for Community Acquired and Nosocomial Infections

*p value significant

In this study,community acquired late onset sepsis were 55.8%.

Among them, Staphylococcus aureus (36%) was the most common organism grown in blood culture. Other organisms include Klebsiella(26%), Escherichia coli (21%, Pseudomonas (5%), Acinetobacter (5%), and Enterococcus (5%). Klebsiella (33.3%) and Staphylococcus (26%) were the most common organisms grown in nosocomial infections^.

Shashi Gandhi et al¹⁴ study of Neonatal Sepsis in Tertiary Care Hospital was done at MG Medical College, Indore. Among 238

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neonates, 32% were blood culture positive. Among culture positive neonates, early onset sepsis was 59% and late onset sepsis was 41%.

77% of PROM developed neonatal sepsis, which was statistically significant p value 0.002.

Anitha B Sethi et al¹⁵ did prospective study on Neonatal sepsis at Niloufer Hospital, Hyderabad. 300 neonates were included in the study.

The result of the study shown in the table.

Table-6: Risk Factors for Neonatal Sepsis

Table-7: Correlation of Risk Factors with Culture Positive Sepsis

Gender, gestational age, birth weight and onset of sepsis had

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SEPSIS:

National Neonatal Forum of India has defined Neonatal sepsis as follows¹⁶:

PROBABLE (CLINICAL) SEPSIS:

In an infant with symptoms of septicemia, if there is the presence of any one of the following criteria:

1. Presence of predisposing factors:

Maternal fever or Foul smelling liquor or

Prolonged rupture of membranes (>24 hrs) or Gastric polymorphs (>5 per high power field)

2. Sepsis screening positive

Presence of any two out of five of the following:

 TLC < 5000/mm

 Band to Total polymorphonuclear cells ratio of >0.2

 Absolute neutrophil count < 1800/cumm,

 C-reactive protein (CRP) >1mg/dl and

 Micro ESR > 10 mm-first hour.

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3. Radiological evidence of pneumonia.

CULTURE POSITIVE SEPSIS:

 Isolation of pathogens from any body fluids

 Autopsy evidence of sepsis.

CLASSIFICATION OF NEONATAL SEPSIS:

¹⁷ Neonatal sepsis is classified into

 Early onset sepsis

 Late onset sepsis

EARLY ONSET SEPSIS (EOS):

When the presentation of sepsis occurs within 72 hours, it is early onset sepsis.

The commonest presentation of EOS is Pneumonia.

The Maternal genital tract is the source of infection.

Factors associated with increased risk of early onset sepsis are as follows: ^17,18

 Low birth weight (<2500 grams) or prematurity

 Febrile illness in the mother with evidence of bacterial infection within 2 weeks prior to delivery

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 Rupture of membranes >24 hours

 Single unclean or > 3 sterile vaginal examination(s) during labour

 Prolonged labour (sum of 1st and 2nd stage of labour > 24 hrs)

 Perinatal asphyxia (Apgar score <4 at 1 minute)

LATE ONSET SEPSIS (LOS):

When the presentation of sepsis occurs after 72 hours, it is late onset sepsis.

The common presentations are septicaemia, pneumonia and meningitis^19,20.

It may be due to nosocomial or community acquired.

Table-8: Risk Factors of Late Onset Sepsis

Nosocomial Community Acquired Prematurity Personal hygiene of care takers

IUGR Poor cord hygiene

NICU admission Artificial feeding Assisted ventilator support Prelacteal feeds Invasive procedures Bad CRP

Parenteral fluids Stock solutions Central and IV lines

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SUBTLE SIGNS OF SEPSIS:

 Temperature instability

 Lethargy

 Refusal of feed

 Circulatory failure presenting as poor perfusion

 Tone abnormality

 Absent neonatal reflex

 Heart rate variation (increased/ decreased)

 Respiratory distress

 Hypo/ hyperglycemia

 Metabolic acidosis

SYSTEMIC MANIFESTATIONS OF SEPSIS

Central nervous system:

High-pitched cry, Bulging anterior fontanelle, seizures, coma, abnormal posture

Cardiovascular System:

Circulatory failure. Griffin et al²¹ found that ECG monitoring helps in the early diagnosis of sepsis. The study revealed that the

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Transient deceleration and reduced variability that occurred 24 hours prior to the onset of symptoms in sepsis. Kovatchev et al²² revealed that the asymmetry of RR interval increased in the 3-4 days before sepsis and greatest increase in the last 24 hours.

Gastrointestinal tract:

Vomiting, diarrhea, distension of abdomen, paralytic ileus, necrotizing enterocolitis (NEC), intolerance of feed.

Hepatic :

Hepatomegaly, direct hyperbilirubinemia

Renal:

Oliguria, prerenal failure

Hematological:

DIVC Dermatological:

Mottling, abscess, pustules, umbilical discharge, sclerema

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DIAGNOSIS:

Table-9: Tool for Sepsis Screening^23,24

Components Abnormal value Total Leukocyte count <5000/ cu.mm

Absolute neutrophil count Low counts as per Manroe chart 25 for term and Mouzinho’s chart 26 for VLBW infants(figure1,2)

Immature/total neutrophil >0.2

Micro-ESR >15 mm in 1st hour C reactive protein (CRP) >1 mg/dl

Presence of any two abnormal parameters is considered as sepsis screen positive with 93-100% of sensitivity, 83% of specificity, 27% of positive and 100 % of negative predictive values.

50% 0f culture positive sepsis have normal WBC counts initially.

The differential count is useful in determining the sepsis. Total neutrophil count is more sensitive than total leukocyte count. About two third of infants have abnormal neutrophil count at the time of symptom onset. Neutropenia is observed in sepsis. Absolute neutrophil count at birth is 1800 cells/cu.mm. It peaks at 12 hours by 7200 cells/cu.mm.

After 72 hours, the value becomes 1800 and remains constant.

The immature to total ratio is the most sensitive in diagnosing the sepsis. The sensitivity of I/T ratio is 60 to 90%. After 72 hours, I/T ratio

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FIGURE 1 MOUZINHO CHART

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FIGURE 2 MANROE’S CHART

ESR is the non-specific marker of inflammation. Edmund Biernacki invented ESR in 1897. It was modified by Westergren. Hence named as Westergren Method. The gold standard method for ESR evaluation is Westergren method. The Micro ESR was first described by Stuart et al^27.

This method requires the glass tube with 1mm internal diameter and length of 75mm or 230 mm^28,29. This needs 0.2 ml of blood^30,31,32. Preet K et³³ al study revealed that micro ESR had very good correlation with the gold standard Westergren method. Similar correlation shown in West BA et al²⁸ and Adhikari BC et al²⁹ in the past.

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West BA et al studied the sensitivity, specificity and predictive values of micro ESR²⁸.

Table-10: Diagnostic Accuracy of Micro ESR

Sensitivity 75.7%

Specificity 48.1%

Positive predictive value 51%

Negative predictive value 73.5%

Table-11: Diagnostic Accuracy of Haematological Parameters

Incidence of thrombocytopenia in sepsis is 10 to 60%. Neonatal sepsis should be suspected when the platelet value <100,000 cells/cu.mm. This is due to platelet clumping and platelet destruction caused by microbes and its products. In neonatal sepsis, the Mean Platelet Volume (MPV) and Platelet Distribution Width (PDW) are higher after 3 days because of newly formed platelets. CRP and micro ESR had positive correlation.

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BLOOD CULTURE

The gold standard diagnostic test for neonatal sepsis is the blood culture. It has to be done before starting antibiotics. The amount of blood required is one ml. The amount of culture media required is 5 to 10 ml.

The strict aseptic precaution should be followed while collecting the blood for culture. The personnel who is drawing the blood should wear a sterile glove and should prepare the skin of at least 5 cm diameter over the veni puncture site. The skin should be wiped with 70% isopropyl alcohol, then with povidone-iodine, and followed by alcohol. The skin should be cleansed in concentric circles moving outward from the centre. Before collecting the blood, the cleansed area should be allowed to dry for at least one minute.

The culture should be observed for three days before labeling it as sterile. The newer culture techniques are BACTEC and ALERT culture system. This can detect organism within 12 to 24 hours and with bacterial concentration of 1 to 2 colony forming unit/ml.

LUMBAR PUNCTURE

The incidence of the neonatal meningitis is 0.3 to 3%^3,19.

The normal CSF findings in term and preterm are shown in the following table.

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Table-12: CSF Findings in Newborn

TEST TERM PRETERM

WBC

Polymorph nuclear cells

7 (0-32) 61%

9 (0-29) 57%

Protein(mg/dl) 90 (20-170) 115 (65-150)

Glucose (mg/dl) 52 (34-119) 50 (24-63)

CSF glucose: Blood glucose 81 (44-248) 74 (55-105)

URINE CULTURE

Presence of one of the following is suggestive of urinary tract infection

 >10 WBC/mm³ in centrifuged urine

 >10⁴ organisms/mL in urine obtained by catheterization and

 Even one organism in urine obtained by suprapubic aspiration

NEWER DIAGNOSTIC MODALITIES

 Acute phase reactants

 Cell surface markers

 Granulocyte colony stimulating factor

 Cytokines

 Molecular genetics

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ACUTE PHASE REACTANTS

These include

 C Reactive protein,

 Procalcitonin,

 Fibronectin,

 Haptoglobin,

 Lactoferrin,

 Neopterin and

 Oromucosoid

C REACTIVE PROTEIN

C Reactive protein is elevated after six hours of exposure to infection. The t ½ of CRP is 19 hours.

PROCALCITONIN

Procalcitonin (PCT) is produced by monocytes and hepatocytes. It increases after four hours after exposure to bacterial endotoxin and the maximum six to eight hours. The half life is 25 to 30 hours. The procalcitonin levels of >2.3 ng/ml indicates a high chance for neonatal sepsis.

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CELL SURFACE MARKERS

Neutrophil CD11b and CD64 are the markers of sepsis.

MANAGEMENT

Supportive Care

Baby should be kept in thermo neutral environment. Oxygen if needed should be provided to the neonate. Euglycemia should be maintained. Fluids and ionotropes used to maintain adequate perfusion.

Oral feeds should be started after hemodynamic stability. Blood and fresh frozen plasma if indicated should be given.

Antibiotics

The antibiotic of choice based on the microorganisms in the NICU unit and their antimicrobial sensitivity. Based on clinical features and a positive septic screen, antibiotics are started.

Table-13: Duration of Antibiotics in Sepsis

DIAGNOSIS DURATION

Meningitis

(with or without positive blood/CSF culture)

21 days

Blood culture positive but no meningitis 14 days Culture negative sepsis (screen positive and clinical

course consistent with sepsis 5-7 days

When to start antibiotics in EOS?

Presence of any one of the following:

 >3 risk factors for early onset sepsis

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 Foul smelling liquor

 ≥2 antenatal risk factor(s) and a positive septic screen and

 Strong clinical suspicion of sepsis.

When to start antibiotics in LOS?

 Sepsis screen positive and/or

 Strong clinical suspicion of sepsis

CHOICE OF ANTIBIOTICS

Empirical antibiotic therapy should be started based on hospital protocol. Antibiotics can be changed based on the culture sensitivity pattern. Antibiotics once started should be modified according to the sensitivity.

Table-14: Empirical Choice of Antibiotics

Clinical Situation Septicemia & Pneumonia Meningitis FIRST LINE

Community-acquired (Resistant strains unlikely)

Penicillin or Ampicillin and Gentamicin

Add

Cefotaxime

SECOND LINE

Hospital-acquired (Some strains are likely to be resistant)

Ampicillin or Cloxacillin

and Gentamicin or Amikacin Add

Cefotaxime

THIRD LINE

Hospital-acquired sepsis (Most strains are Likely to be resistant)

Cefotaxime or Piperacillin- Tazobactam or

Ciprofloxacin and Amikacin;

Same (Avoid Cipro)

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EXCHANGE TRANSFUSION (ET)

Studies shown that the double volume exchange transfusion had 50% reduction in mortality due to sepsis in severe septic neonates with sclerema³⁴.

INTRAVENOUS IMMUNOGLOBULIN (IVIG):

The role of IVIG in neonatal sepsis are

 To enhance opsonisation of micro organisms

 Its phagocytosis

 Causes complement activation

 Neutrophil chemotaxis.

The adverse effects are transfusion related complications. Non - specific pooled IVIG is not used in sepsis³⁵.

GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (GM-CSF):

Indicated when the neutrophil count is very much depleted. The adverse effects of granulocyte transfusion are infections like CMV, hepatitis B, graft versus host reaction and pulmonary sequestration of leukocytes. This therapy is under trial³⁶.

RECOMBINANT HUMAN CYTOKINE

Granulocyte progenitor cells are stimulated by recombinant human cytokine. They have promising results in animal models.

(41)

MATERIALS AND METHODS

STUDY DESIGN

Cross sectional study

STUDY POPULATION

Newborns with signs/ symptoms of sepsis and sepsis screen positive-any 2 or more positive among following 5 parameters

Total count ( <5000 )

Absolute neutrophil count low count as per standard normograms for gestational age

Immature to total neutrophil >= 0.2 Micro ESR >= 15mm in first hour CRP >= 1 mg/dl

STUDY PERIOD

JUNE 2018 TO MAY 2019

SAMPLE SIZE

957

STUDY SETTING

ISP SNCU (Extramural)

(42)

INCLUSION CRITERIA

Newborns admitted in SNCU ,ISP and NICU RSRM with sepsis screen positive

EXCLUSION CRITERIA

Nil

METHODOLOGY

After obtaining ethics committee approval, after obtaining informed written consent from parents/caretakers/guardian of newborns admitted with signs and symptoms of sepsis, Venous blood drawn for complete blood count, CRP ,blood culture and bedside MicroESR did in capillary blood. Newborns who were positive for sepsis screen were enrolled in the study .Relavent information obtained and recorded in a predesigned proforma . Neonates were managed according to our hospital protocol . All neonates enrolled in the study were followed throughout their hospital stay/death .Risk factors associated with sepsis and outcome of neonatal sepsis were analysed.

STATISTICAL ANALYSIS

The collected data were analysed with IBM. SPSS statistics software 23.0 Version. To describe about the data descriptive statistics frequency analysis, percentage analysis were used for categorical variables and the mean & S.D were used for continuous variables. To find the significance in categorical data Chi-Square test was used

(43)

similarly if the expected cell frequency is less than 5 in 2×2 tables then the Fisher's Exact was used. In all the above statistical tools the probability value 0.05 is considered as significant level.

CONFLICT OF INTEREST

None

PRIVACY/ CONFIDENTIALITY OF STUDY SUBJECTS

Privacy of the subjects shall be maintained.

SPONSER DETAILS

None

(44)

STATISTICAL ANALYSIS

Total neonates included in the study - 957 Total no of cases in Intramural NICU – 845 Early onset sepsis – 743

Late onset sepsis – 102

Total no of cases in Extramural SNCU – 112 Early onset sepsis – 57

Late onset sepsis – 55 Table-15: Outline of the Results

Total

(957) EOS LOS Recovery Death Culture proven

sepsis

Death in culture proven sepsis Intra

Mural

Number

845

743 102 804 41 72 8

Percentage 88 12 95 5 9 11

Extra Mural

Number

112

57 55 108 4 29 2

Percentage 50.8 49.2 96.4 3.6 25.5 8

(45)

RISK FACTOR ANALYSIS IN INTRAMURAL NEONATES:

Total no of cases included- 845 Early Onset Sepsis- 743(88%) Late Onset Sepsis- 102 (12%)

Total no of Culture Proven Sepsis cases- 72 (9%)

Total no of Death in Intramural neonates with sepsis- 41(5%) Total no of Death in Intramural neonates with Culture positive sepsis-8 cases

(46)

Among 845 neonates, 50.7%(423) were male and 49.3%(417) were female. Almost equal distribution was observed.

Mothers of 522(62%) neonates were primi gravida. Mothers of 24.3%(202) neonates were 2^nd gravida.

(47)

Table-16: Maternal Risk Factors in Intramural Sepsis

MATERNAL RISK

FACTORS NUMBER

(n=845) PERCENT (%) HEMOGLOBIN

>10 gm/dl 450 53.3

8 to 10 gm/dl 313 37

<8 gm/dl 82 9.7

PIH

YES 149 17.6

NO 696 82.4

GDM

YES 128 15

NO 717 85

MATERNAL FEVER WITHIN 2 WEEKS PRIOR TO DELIVERY

YES 98 11.6

NO 747 88.4

QUANTITY OF LIQUOR

NORMAL 664 78.6

OLIGO HYDRAMINOS 132 15.6

POLY HYDRAMINOS 49 5.8

H/O UTI

YES 54 6.4

NO 791 93.6

(48)

Table-17: Natal Risk Factors in Intramural Sepsis

NATAL RISK FACTORS NUMBER (n=845) PERCENT (%) PLACE OF DELIVERY

HOME/ TRANSIT 13 1.5

PHC/GH 20 2.4

TERTIARY CARE 812 96.1

PRIVATE HOSPITAL 0 0

MODE OF ONSET OF LABOUR

SPONTANEOUS 683 80.8

INDUCED 142 16.8

MEMBRANES RUPTURED OUTSIDE

YES 210 24.9

NO 635 75.1

PROLONGED RUPTURE OF MEMBRANES

YES 107 12.7

NO 738 87.8

MODE OF DELIVERY

NVD 455 53.8

AVD 107 12.7

ELECTIVE LSCS 20 2.4

EMERGENCY LSCS 263 31.1

LIQUOR

NORMAL 706 83.6

BLOOD STAINED 7 15.6

MECONIUM STAINED 132 0.8

(49)

46.7%(393) mothers of neonates had anaemia. 17.6% (149) of the mothers had PIH. 15% (128) had Gestational diabetes mellitus.

11.6%(98) mothers had fever within 2 weeks prior to the delivery. 6.4%

had urinary tract infection.

2.4% (20) neonates were delivered in PHC/GH. 13 neonates were born at home and during transit. 16.8% neonates were born through induced labour. 24.9%(210) mothers had membranes ruptured outside the hospital. 107(12.7%) mothers had PROM. 12.7% (107) neonates were born through assisted vaginal delivery. 15.6% mothers had meconium stained liquor during delivery.

Among 845 neonates, 37% were low birth weight babies.

60%(498) had normal birth weight.

(50)

Among 845, 14% neonates were small for gestational age. 4.5%

were large for gestational age.

Out of 845 babies, 27.8%(235) neonates were preterm and 4.3%

were post dated newborns.

(51)

Table-18: Neonatal Risk Factors in Intramural Sepsis NEONATAL RISK

(n=845) PERCENT (%) BIRTH WEIGHT

<2.5 kg 313 37

2.5 to 4kg 498 60

>4 kg 34 3

WEIGHT FOR GESTATIONAL AGE

SGA 116 14

AGA 689 81.5

LGA 40 4.5

MATURITY

PRETERM 235 27.8

TERM 574 67.9

POST DATED 36 4.3

BIRTH ASPHYXIA

NO 724 86

YES 121 14

CORD CARE

GOOD 823 97.4

POOR 22 2.6

PRELACTEAL FEEDS

YES 22 2.6

NO 823 97.4

BAD CRP

YES 31 3.7

NO 814 96.3

(52)

Among the neonatal sepsis cases included in the study, 14%(121) had birth asphyxia. 2.6% (22) had poor cord hygiene. 2.6%(22) had given Prelacteal feeds to babies and 3.6%(31) followed bad child rearing practices.

Among 845 newborns, 72 cases were culture proven sepsis.

(53)

The most common organism isolated from blood culture was Klebsiella(36.9%). Other organisms isolated were Acinetobacter, Pseudomonas, E.coli, Staphylococcus aureus, Proteus and Citrobacte r. 2.

1% had culture positive for Non Candida albicans.

(54)

Among 845 neonates, 5%(41 babies) died due to neonatal sepsis.

95%(804 babies) recovered and discharged successfully.

(55)

RISK FACTOR ANALYSIS IN INTRAMURAL NEONATES FOR EARLY ONSET SEPSIS:

Among 845 babies, 743 had early onset sepsis(88%).

Among 743 EOS babies, 51.1% were male and 48.9% were female.

(56)

Table-19: Maternal Risk Factors –EOS in Intramural Sepsis

MATERNAL RISK FACTORS

NUMBER

(n=743) PERCENT (%) MATERNAL AGE

<20 YRS 95 12.8

20 TO 30 YRS 559 75.2

>30 YRS 89 12

GRAVIDA

PRIMI 458 61.6

GRAVIDA 2 183 24.6

GRAVIDA 3 68 9.2

GRAVIDA >3 34 4.6

HEMOGLOBIN

>10 gm/dl 400 53.8

8 to 10 gm/dl 268 36.1

<8 gm/dl 15 10.1

PIH

YES 133 17.9

NO 610 82.1

GDM

YES 114 15.3

NO 628 84.7

(57)

MATERNAL RISK

(n=743) PERCENT (%) MATERNAL FEVER WITHIN 2 WEEKS PRIOR TO DELIVERY

YES 82 11

NO 661 89

NORMAL 582 78.3

H/O UTI

YES 49 6.6

NO 694 93.4

12.8% (95) of mothers belonged to the group less than 20 years.

61.6%(458) newborns were born to primi mothers. 46.1%(283) mothers had anemia. 17.9%(133) mothers had PIH and 1 5.3%(114) mothers had GDM. 11% had maternal fever and 6.6% had UTI.

(58)

Table-20: Natal Risk Factors for EOS in Intramural Sepsis

HOME/ TRANSIT 13 1.7

PHC/GH 18 2.4

TERTIARY CARE 712 95.8

SPONTANEOUS 604 81.3

INDUCED 125 16.7

YES 189 25.4

NO 554 74.6

YES 101 13.6

NO 642 86.4

NVD 414 55.7

AVD 95 12.8

ELECTIVE LSCS 14 1.9

LIQUOR

NORMAL 619 83.3

BLOOD STAINED 7 0.9

(59)

1.7%(13) babies delivered in home/ during transit and 18 babies delivered in PHC.

16.7% babies were born through induced labour. 25.4%(189) mothers had membranes ruptured outside before reaching the hospital.

13.6%(101) mothers had PROM.

12.8% delivered through assisted vaginal delivery. 15.7%(117) had meconium stained amniotic fluid.

38.9%(289) were low birth weight babies.

(60)

15%(108) were small for gestational age.

Among 743 newborns, 29.3%(218) were born prematurely.

Postdated delivery were 4.2%.

(61)

Table-21: Neonatal Risk Factors- EOS in Intramural Sepsis

NEONATAL RISK

<2.5 kg 289 38.9

2.5 to 4kg 425 57.2

>4 kg 29 3.9

SGA 108 15

AGA 600 80.3

LGA 35 4.7

MATURITY

PRETERM 218 29.3

TERM 494 66.5

POST DATED 31 4.2

BIRTH ASPHYXIA

NO 622 83.7

YES 121 16.3

CORD CARE

GOOD 725 97.3

POOR 18 2.7

(62)

NEONATAL RISK

(n=743) PERCENT (%) PRELACTEAL FEEDS

YES 25 3.3

NO 718 96.7

BAD CRP

YES 17 2.2

NO 726 97.8

121 babies had birth asphyxia. 2.7% had poor cord care. 2.2%

(17) admitted with h/o bad CRP.

Out of 743 EOS babies, 9% had culture proven sepsis.

(63)

Among 743 babies, 707 babies recovered and 5.2% (39) died due to early onset sepsis.

(64)

RISK FACTOR ANALYSIS IN INTRAMURAL NEONATES LATE ONSET SEPSIS:

Among 847 babies, 102 had late onset sepsis(12%). 48.9% were female and 47.1% were males.

(65)

Table-22: Maternal Risk Factors- LOS in Intramural Sepsis MATERNAL RISK

FACTORS

NUMBER

(n=102) PERCENT (%) MATERNAL AGE

<20 YRS 13 12.7

20 TO 30 YRS 73 71.6

>30 YRS 16 15.7

GRAVIDA

PRIMI 64 62.7

GRAVIDA 2 22 21.6

GRAVIDA 3 14 13.7

GRAVIDA >3 2 2.0

HEMOGLOBIN

>10 gm/dl 50 49

8 to 10 gm/dl 45 44.1

<8 gm/dl 7 6.9

PIH

YES 16 15.7

NO 86 84.3

GDM

YES 14 13.7

NO 88 86.3

MATERNAL FEVER WITHIN 2 WEEKS PRIOR TO DELIVERY

YES 16 15.7

NO 86 84.3

(66)

MATERNAL RISK FACTORS

NUMBER

(n=102) PERCENT (%) QUANTITY OF LIQUOR

NORMAL 82 80.4

H/O UTI

YES 5 4.9

NO 97 95.1

12.7%(13) of mothers belonged to the group less than 20 years.

62.7%(64) newborns were born to primi mothers. 51%(52) mothers had anemia. 15.7% mothers had PIH and 13.7% mothers had GDM.

15.7%(16) had maternal fever and 4.9% had UTI.

(67)

Table-23: Natal Risk Factors- LOS in Intramural Sepsis

HOME/ TRANSIT 0 0

PHC/GH 2 2

TERTIARY CARE 100 98

SPONTANEOUS 79 77.5

INDUCED 17 16.7

YES 21 20.6

NO 81 79.4

YES 6 5

NO 96 95

NVD 41 40.2

AVD 12 11.8

ELECTIVE LSCS 6 5.9

LIQUOR

NORMAL 87 81.8

BLOOD STAINED 0 0

(68)

2 babies delivered in PHC were admitted with LOS.

16.7%(17)babies were born through induced labour. 20.6%(21) mothers had membranes ruptured outside before reaching the hospital. 5%(6) mothers had PROM. 11.8% delivered through assisted vaginal delivery.

18.2%(15) had meconium stained amniotic fluid.

23.5% had low birth weight.

(69)

Small for gestational age in LOS group were 15%

16.7%(17 babies) were born prematurely in LOS group.

(70)

Table-24: Neonatal Risk Factors – LOS in Intramural Sepsis NEONATAL RISK

FACTORS

NUMBER

<2.5 kg 24 23.5

2.5 to 4kg 73 71.6

>4 kg 5 4.9

SGA 8 7.8

AGA 89 87.3

LGA 5 4.9

MATURITY

PRETERM 17 16.7

TERM 80 78.4

POST DATED 5 4.4

BIRTH ASPHYXIA

NO 0 0

YES 102 100

CORD CARE

GOOD 89 87.3

POOR 13 12.7

YES 18 17.6

NO 84 82.4

(71)

NEONATAL RISK FACTORS

NUMBER

(n=102) PERCENT (%) BAD CRP

YES 24 23.5

NO 78 76.5

12.7% (13) had poor cord care. 18 babies were given Prelacteal feeds. 23.5% (24) admitted with h/o bad CRP.

Out of 102 babies,7% babies had culture positive sepsis.

(72)

Among 102 babies, 95% recovered and 5% died due to sepsis.

(73)

Table-25: Association of Mode of Delivery with Sepsis

MODE OF DELIVERY Groups

Total EOS LOS

NVD Count 414 41 455

% 55.7% 40.2% 53.8%

AVD Count 95 12 107

% 12.8% 11.8% 12.7%

ELECTIVE LSCS Count 14 6 20

% 1.9% 5.9% 2.4%

EMERGENCY LSCS Count 220 43 263

% 29.6% 42.2% 31.1%

Total Count 743 102 845

% 100.0% 100.0% 100.0%

Value df Asymptotic Significance (2-sided)

Pearson Chi-Square 14.682b 3 .002

Likelihood Ratio 13.110 3 .004

Linear-by-Linear Association 9.932 1 .002

N of Valid Cases 845

Mode of delivery had statistical significance with p value of 0.002.

(74)

Table-26: Association of Birth Asphyxia and Sepsis

BIRTH ASPHYXIA Groups

Total

EOS LOS

NO Count 622 102 724

% 83.7% 100.0% 85.7%

YES Count 121 0 121

% 16.3% 0.0% 14.3%

% 100.0% 100.0% 100.0%

Value df

Asymptotic Significance

(2-sided)

Exact Sig.

(2- sided)

Exact Sig.

(1- sided) Pearson Chi-Square 19.387b 1 .000

Continuity

Correctionc 18.083 1 .000

Fisher's Exact Test .0005 .000

Linear-by-Linear

Association 19.364 1 .000

Birth Asphyxia had statistical significance with Sepsis with p value of 0.0005.

(75)

Table-27: Association of Cord Hygiene with Sepsis

CORD HYGIENE Groups

Total

EOS LOS

GOOD Count 734 89 823

% 98.8% 87.3% 97.4%

POOR Count 9 13 22

% 1.2% 12.7% 2.6%

% 100.0% 100.0% 100.0%

Value df Asymptotic Significance

(2-sided)

Exact Sig.

(2-sided)

Exact Sig.

(1-sided) Pearson

Chi-Square 47.051b 1 .0005 Continuity

Likelihood

Ratio 28.786 1 .000

Fisher's

Exact Test .000 .000

Linear-by- Linear

N of Valid

Cases 845

Cord hygiene had statistical significance with p value of 0.0005.

(76)

Table-28: Association of Bad CRP with Sepsis

BAD CRP Groups

Total

EOS LOS

YES Count 7 24 31

% .9% 23.5% 3.7%

NO Count 736 78 814

% 99.1% 76.5% 96.3%

% 100.0% 100.0% 100.0%

(2-sided)

Exact Sig.

(2-sided)

Exact Sig.

Correctionc 123.163 1 .000 Likelihood

Ratio 75.238 1 .000

Fisher's

Linear-by- Linear

Association 129.322 1 .000 N of Valid

Cases 845

Bad CRP had statistical significance with p value of 0.0005.

(77)

Table-29: Association of Maternal Fever with Outcome MATERNAL FEVER

WITHIN 2 WEEKS PRIOR TO DELIVERY

OUTCOME

Total RECOVERY DEATH

YES Count 98 0 98

% 12.2% 0.0% 11.6%

NO Count 706 41 747

% 87.8% 100.0% 88.4%

% 100.0% 100.0% 100.0%

(2-sided)

Exact Sig.

(2-sided)

Exact Sig.

Chi-Square 5.653b 1 .017

Continuity

Likelihood

Ratio 10.379 1 .001

Fisher's

Linear-by- Linear Association

5.646 1 .017

N of Valid

Cases 845

Maternal fever had statistical significance with outcome with p value of 0.010.

(78)

Table-30: Association of PROM with Outcome

PROM OUTCOME

Total RECOVERY DEATH

YES Count 93 14 107

% 11.6% 34.1% 12.7%

NO Count 711 27 738

% 88.4% 65.9% 87.3%

% 100.0% 100.0% 100.0%

(2-sided)

Exact Sig.

(2-sided)

Exact Sig.

Likelihood

Ratio 13.424 1 .000

Fisher's

Linear-by- Linear

N of Valid

Cases 845

PROM had statistical significance with outcome with p value of 0.0005.

(79)

Table-31: Association of Liquor with Outcome

LIQUOR OUTCOME

Total RECOVERY DEATH

NORMAL Count 681 25 706

% 84.7% 61.0% 83.6%

BLOOD STAINED Count 4 3 7

% .5% 7.3% .8%

MECONIUM STAINED Count 119 13 132

% 14.8% 31.7% 15.6%

% 100.0% 100.0% 100.0%

Value df Asymptotic

Significance (2- sided) Pearson Chi-

Square 31.667b 2 .0005

Likelihood

Ratio 17.449 2 .000

Linear-by- Linear

N of Valid

Cases 845

Liquor had statistical significance with outcome with p value of 0.0005.

(80)

Table-32: Association of Maturity with Outcome

MATURITY OUTCOME

PRETERM Count 212 23 235

% 26.4% 56.1% 27.8%

TERM Count 560 14 574

% 69.7% 34.1% 67.9%

POST DATED Count 32 4 36

% 4.0% 9.8% 4.3%

% 100.0% 100.0% 100.0%

Maturity of the neonates had statistical significance with outcome with p value of 0.0005.

(81)

Table-33: Association of Birth Asphyxia with Outcome

BIRTH ASPHYXIA

OUTCOME

NO Count 701 23 724

% 87.2% 56.1% 85.7%

YES Count 103 18 121

% 12.8% 43.9% 14.3%

% 100.0% 100.0% 100.0%

Value df Asymptotic Significance

(2-sided)

Exact Sig.

(2-sided)

Exact Sig.

(1-sided) Pearson Chi-

Square 30.737b 1 .0005

Continuity

Correctionc 28.255 1 .000 Likelihood Ratio 22.387 1 .000 Fisher's Exact

Test .000 .000

Linear-by-Linear

Association 30.700 1 .000 N of Valid Cases 845

Birth Asphyxia had statistical significance with outcome with p

(82)

Table-34: Association of PROM with Blood Culture

Value df

Asymptotic Significance

(2-sided)

Exact Sig.

(2-sided)

Exact Sig.

Chi-Square 4.751b 1 .029

Continuity

Likelihood

Ratio 4.151 1 .042

Fisher's

Linear-by- Linear

N of Valid

Cases 845

PROM had statistical significance with blood culture with p value of 0.029.

PROM BLOOD CULTURE

Total POSITIVE NEGATIVE

YES Count 15 92 107

% 20.8% 11.9% 12.7%

NO Count 57 681 738

% 79.2% 88.1% 87.3%

Total

Count 72 773 845

% 100.0% 100.0% 100.0%

(83)

Table-35: Association of Maturity with Blood Culture

MATURITY BLOOD CULTURE

Total POSITIVE NEGATIVE

PRETERM Count 29 206 235

% 40.3% 26.6% 27.8%

TERM Count 41 533 574

% 56.9% 69.0% 67.9%

POST DATED Count 2 34 36

% 2.8% 4.4% 4.3%

% 100.0% 100.0% 100.0%

Maturity of neonates had statistical significance with blood culture with p value of 0.045.

(84)

RISK FACTOR ANALYSIS IN EXTRAMURAL NEONATES

Total no of cases included- 112

Early onset sepsis- 57 (50.8%) Late onset sepsis- 55 (49.2%)

Total no of Culture Proven Sepsis cases- 29 (25.5%)

Total no of Death in Extramural neonates with sepsis- 4 (3.6%) Total no of Death in Extramural neonates with Culture positive sepsis- 2 cases

MATERNAL RISK FACTORS

54% of mothers in EOS group had anemia whereas 71% of mothers in LOS group had anemia. In EOS group, 15% had PIH and 22% had GDM. 7%(4) had maternal fever in EOS groups. In EOS group, 6% had UTI. Only 3% had UTI in LOS group.

(85)

Table-36: Maternal Risk Factors in Extramural Sepsis

Maternal risk factors

Total Eos Los

Number

(n=112) Percent (%)

Number (n=57)

Percent

(%) Number

(n=55) Percent (%) HEMOGLOBIN

>10 gm/dl 42 37.5 26 45.6 16 29

8 to 10 gm/dl 61 54.5 28 49.1 33 60

<8 gm/dl 9 8 3 5.3 6 11

PIH

YES 21 18.8 9 15 12 22

NO 79 81.2 48 85 43 78

GDM

YES 23 20.5 12 22 11 20

NO 89 79.5 45 78 44 80

MATERNAL WITHIN FEVER 2 WEEKS PRIOR TO DELIVERY

YES 7 6.3 4 7 3 6

NO 105 93.7 53 93 52 94

NORMAL 86 76.8 42 73.7 44 80

OLIGO

HYDRAMINOS 17 15.2 9 15.8 8 14.5

POLY

HYDRAMINOS 9 8 6 10.5 3 5.5

H/O UTI

YES 8 7.1 6 10.5 2 3.6

NO 104 92.9 51 89.5 53 96.4

(86)

Table-37: Natal Risk Factors in Extramural Sepsis

Natal risk factors

Number

(n=112) Percent

(%) Number

(n=57) Percent (%)

Number (n=55)

Percent (%) PLACE OF DELIVERY

Home/ Transit 3 2.7 3 5.3 0 0

Phc/Gh 46 41 36 63.2 11 20

Tertiary care 35 31.3 0 0 34 61.8

Private hospital 28 25 18 31.5 10 18.2

Spontaneous 92 82.1 47 82.5 45 81.8

Induced 6 5.4 2 3.5 4 7.3

YES 11 9.8 6 10.5 5 9.1

NO 101 90.2 51 89.5 50 90.9

Yes 12 10.7 0 0 12 21.8

No 100 89.3 57 100 43 78.2

NVD 64 57.1 29 59.8 35 63.6

AVD 5 4.5 0 0 5 9.1

Elective lscs 15 13.4 10 17.5 5 9.1

Emergency

LSCS 28 25 18 31.6 10 18.2

LIQUOR

Normal 86 76.8 41 72 45 81.8

Blood stained 1 0.9 1 1.8 0 0

Meconium

stained 25 22.3 15 26.2 10 18.2

31.5% of the EOS mothers delivered baby in private hospital(18).

10.5%(6 mothers) had MRO in EOS. In LOS group, 21.8% had PROM.

Among EOS group of 57, 26.2% had meconium stained liquor.

(87)

Table-38: Neonatal Risk Factors in Extramural Sepsis

Neonatal risk factors

Number

(n=112) Percent

(%) Number

(n=57) Percent

(%) Number

(n=55) Percent (%) BIRTH WEIGHT

<2.5 kg 42 37.5 18 31.6 24 43.6

2.5 to 4kg 64 58.9 36 63.2 30 54.5

>4 kg 4 3.6 3 5.2 1 1.8

SGA 22 19.6 10 17.5 12 22

AGA 86 76.8 44 77.2 42 76.2

LGA 4 3.6 3 5.3 1 1.8

MATURITY

PRETERM 25 22.3 12 21.1 13 23.8

TERM 77 68.8 38 66.7 39 70.9

POST

DATED 10 8.9 7 12.3 3 5.5

BIRTH ASPHYXIA

NO 84 75 40 70.2 44 20

YES 28 25 17 29.8 11 80

CORD CARE

GOOD 103 92 57 100 46 83.6

POOR 9 8 0 0 9 16.4

YES 18 16.1 6 10.5 12 22

NO 94 83.9 51 89.5 43 78

(88)

Neonatal risk factors

Number (n=112)

Percent (%)

Number (n=57)

Percent (%)

Number (n=55)

Percent (%) BAD CRP

YES 19 17 2 3.5 17 30.9

NO 93 83 55 96.5 39 69.1

H/O NICU ADMISSION

YES 24 21.4 0 0 20 37

NO 88 78.6 57 100 35 63

31.8% (18) babies were low birth weight in EOS whereas in LOS this was 43.6%(24 babies). Out of 57 EOS babies, 17.5% of babies were under SGA group and 5.3% were LGA group. 21.1% and 23.8% were born prematurely in EOS and LOS group respectively. Birth asphyxia accounted for 25%(28 babies) of extramural sepsis. 16.4% (9 babies) had poor cord care in LOS group. 30.9% (17) followed bad CRP and 22%(12) given prelacteal feeds in LOS group.

(89)

52.7% were male and 47.3% were female.

Among 112 babies, 37.5% were low birth weight.

(90)

Out of 112 , 20% of babies were SGA.

Among 112, preterm babies were 22.3% and 8.9% were post dated newborns.

(91)

25% of extramural neonates had birth asphyxia.

In extramural neonates, 21.4% had previous history of NICU admission.

(92)

Among 112 sepsis screen positive newborns in extramural settings, 25% were found to be culture proven sepsis(29 babies).

In extramural neonates, 3.6% died and 96.4% recovered and successfully discharged.

(93)

The most common organisms grown in culture were acinetobacter and klebsiella. Others include MRSA, Coagulase negative Staphylococus aureus, Pseudomonas, Enterococcus, Proteus and E.coli.

(94)

Table-39: Association of Place of Delivery in Extramural Sepsis

PLACE OF DELIVERY Groups

Total EOS LOS

HOME/TRANSIT Count 3 0 3

% 5.3% 0.0% 2.7%

PHC/GH Count 35 11 46

% 61.4% 20.0% 41.1%

TERTIARY CARE CENTRE

Count 1 34 35

% 1.8% 61.8% 31.3%

PRIVATE Count 18 10 28

% 31.6% 18.2% 25.0%

% 100.0% 100.0% 100.0%

‌ Value df Asymptotic Significance (2-sided)

Place of delivery had statistically significant association with sepsis.

P value for this association is 0.0005.

“RISK FACTOR ANALYSIS FOR NEONATAL SEPSIS AND THE OUTCOME IN TERTIARY CARE