| CTRI Number |
CTRI/2013/04/003601 [Registered on: 30/04/2013] Trial Registered Retrospectively |
| Last Modified On: |
24/10/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
causes and outcome of neonatal enterocolitis |
|
Scientific Title of Study
|
Clinical profile and risk factors for necrotising enterocolitis in South Indian population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bahubali D Gane |
| Designation |
Ph. D scholor |
| Affiliation |
JIPMER |
| Address |
DIVISION OF NEONATOLOGY(ward no 30)
DEPARTMENT OF PEDIATRICS
JIPMER
PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
919489966496 |
| Fax |
|
| Email |
bahubaligane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VISHNU BHAT B |
| Designation |
Head of the department |
| Affiliation |
JIPMER |
| Address |
DIVISION OF NEONATOLOGY(ward no 30)
DEPARTMENT OF PEDIATRICS
JIPMER
PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9842351282 |
| Fax |
|
| Email |
drvishnubhat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Bahubali D Gane |
| Designation |
Ph. D scholor |
| Affiliation |
JIPMER |
| Address |
DIVISION OF NEONATOLOGY(ward no 30)
DEPARTMENT OF PEDIATRICS
JIPMER
PONDICHERRY
PONDICHERRY
605006
India |
| Phone |
919489966496 |
| Fax |
|
| Email |
bahubaligane@gmail.com |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH (JIPMER) |
|
|
Primary Sponsor
|
| Name |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH JIPMER |
| Address |
DHANVANTRI NAGAR
GORIMEDU
PONDICHERRY |
| 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 |
| DRBAHUBALI DGANE |
NICU (WARD NO 30) |
WARD NO 30
NICU
Department of Pediatrics
JIPMER
DHANVANTRI NAGAR
PONDICHERRY
Pondicherry
PONDICHERRY |
9489966496
bahubaligane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patents with Necrotizing enterocolitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All babies born in JIPMER with NEC |
|
| ExclusionCriteria |
| Details |
(a) Babies born out side JIPMER
(b) Babies who survive <24 hours
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| total duration of hospital stay, death, surgical intervention needed |
AT the time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maternal and Neonatal risk factors associated with Necrotizing enterocolitis |
At the time of of discharge |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The babies born in JIPMER with NEC will be included in the study. Antenatal and intrapartum and post natal details will be collected. one neonate of same gestational age and sex will be taken as control. same details will be collected for controls. Stage of NEC will be recorded based on Modified Ballards score. Events during hospital stay till discharge will be recorded. |