| 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
|
|
|
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
|
|
|
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. |