FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073786 [Registered on: 11/09/2024] Trial Registered Prospectively
Last Modified On: 06/09/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Incidence of Infection in newborn babies born to mothers with rupture of baby sac membrane 
Scientific Title of Study   Incidence of neonatal sepsis among neonates between 28-36 weeks of gestation to mothers with varying duration of rupture of membrane 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anitha Haribalakrishna 
Designation  Associate Professor and Head of Department 
Affiliation  Seth G.S. Medical College & KEM Hospital 
Address  Department of Neonatology 10th floor New Building KEM Hospital Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9769660870  
Fax    
Email  ani.gem81@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anitha Haribalakrishna 
Designation  Associate Professor and Head of Department 
Affiliation  Seth G.S. Medical College & KEM Hospital 
Address  Department of Neonatology 10th floor New Building KEM Hospital Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9769660870  
Fax    
Email  ani.gem81@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anitha Haribalakrishna 
Designation  Associate Professor and Head of Department 
Affiliation  Seth G.S. Medical College & KEM Hospital 
Address  Department of Neonatology 10th floor New Building KEM Hospital Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9769660870  
Fax    
Email  ani.gem81@gmail.com  
 
Source of Monetary or Material Support  
Department of Neonatology, New building, 10th floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai 
 
Primary Sponsor  
Name  Seth GS Medical College and KEM Hospital 
Address  Department of Neonatology New building, 10th floor, KEM Hospital, Parel, Mumbai 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anitha Haribalakrishna  Seth GS Medical College and KEM Hospital  Department of Neonatology, New building, 10th floor KEM Hospital, Parel Mumbai
Mumbai
MAHARASHTRA 
02224107035

ani.gem81@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)-II Relating to Biomedical and Health research (BHR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P011||Newborn affected by premature rupture of membranes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Neonates born to mother who delivered at KEM hospital with gestational age between 28-36 weeks with history of leaking Per vaginum 
 
ExclusionCriteria 
Details  Neonates born in hospital setting other than KEMH are excluded.
Neonates born to mother without history of leaking PV are excluded.
Neonates born to mother who are not registered antenatally at KEMH are excluded.
Neonates born with serious systemic illnesses, e.g. lung and heart diseases and with fetal congenital abnormality are excluded
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
EOS in preterm infants of 28-36 weeks gestation born with history of preterm premature rupture of membranes of any duration  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of neonatal sepsis among neonates born between 28-36 weeks of gestation to mothers with rupture of membrane for less than and more than 18 hours duration
All cause mortality of the included study infants
Incidence of neonatal shock among these neonates
Incidence of bronchopulmonary dysplasia
Incidence of NEC
Time to reach full feeds
Time to regain birth weight
Intraventricular hemorrhage
Periventricular leukomalacia
Incidence of feed intolerance
PDA
Duration of hospital stay
Neurological abnormality at discharge
 
28 days 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Sepsis is one of the most common causes of neonatal deaths globally (ref). The incidence of neonatal early onset sepsis has declined substantially over the last 2 decades, primarily because of the implementation of evidence based intrapartum antimicrobial therapy (ref). However neonatal sepsis remains a serious and potentially fatal illness (ref). The incidence of neonatal sepsis is 14.3 % and of culture positive sepsis is 6.2% in low and middle income countries like India (ref)(DeNIS trail).                  
Prolonged prelabour premature rupture of membranes (PPPROM) is rupture of amniotic membrane lasting for more than 18 hrs before onset of  labour in preterm gestation. Following PPPROM, approximately 50 % of women will deliver within one week.(ref). Majority of these infants born to women with PPPROM are exposed to risks associated with prematurity including respiratory distress syndrome (RDS), early onset sepsis (EOS), necrotizing enterocolitis (NEC), intraventricular haemorrhage (IVH), retinopathy of prematurity (ROP) as well as risks of cerebral palsy, blindness and deafness (ref).
                    Clinical chorioamnionitis has been reported to occur in 15 – 25% of pregnancies complicated by PPPROM, with subclinical infection being considerably more common (ref). Chorioamnionitis may present shortly after PPPROM and may result in preterm labor. Chorioamnionitis, diagnosed both clinically and histologically, was associated with early and late onset sepsis in neonates especially preterms (ref).
It is our unit practice to suspect sepsis in any preterm neonate born to mother with PPPROM of any duration and to initiate intravenous antibiotics emperically, though evidence has shown increased association of EOS with PPPROM>18 hours (ref). This is due to the fact that the incidence of EOS in these groups are relatively high in our set up. However, the evidence regarding the association of EOS with PPPROM of shorter duration is limited from low and middle income countries like India.
Given the fact that majority of preterm babies admitted in our NICU fall in the age group of 28-36 weeks gestation, we decided to prospectively observe the association of PPROM of any duration with EOS in preterm infants of 28 to 36 weeks gestation. Further we decided to compare the incidence of EOS in preterm infants born with rupture of membranes >18 hours with those born with rupture of membranes <18 hours.
 
Close