| CTRI Number |
CTRI/2024/01/061086 [Registered on: 03/01/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Randomised control Pilot Trial comparing two care pathways] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Pilot Randomised Study comparing the effect of feeding during blood transfusion on Transfusion associated Necrotising Enterocolitis in premature babies. |
|
Scientific Title of Study
|
Stopping Versus Continuing Enteral Feeds Around Red Cell Transfusion and its Effect on Transfusion Associated Necrotising Enterocolitis in Preterm Neonates : A Pilot Randomised Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiran More |
| Designation |
Senior Consultant |
| Affiliation |
Bai Jerbai Wadia Hospital for Children,Mumbai |
| Address |
Department of Neonatology, 2nd floor NICU , Bai Jerbai Wadia Hospital for Children, Acharya Donde Marg, Parel,Mumbai,Maharashtra 400 012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7045161408 |
| Fax |
|
| Email |
drkiranmore@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Moushmi Hosalkar |
| Designation |
DrNB Neonatology Resident |
| Affiliation |
Bai Jerbai Wadia Hospital for Children, Mumbai |
| Address |
Department of Neonatology, 2nd floor NICU,Bai Jerbai Wadia Hospital for Children, Acharya Donde Marg, Parel,Mumbai,Maharashtra 400 012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9867016644 |
| Fax |
|
| Email |
moushmi792@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Moushmi Hosalkar |
| Designation |
DrNB Neonatology Resident |
| Affiliation |
Bai Jerbai Wadia Hospital for Children, Mumbai |
| Address |
Department of Neonatology, 2nd floor NICU,Bai Jerbai Wadia Hospital for Children, Acharya Donde Marg, Parel,Mumbai,Maharashtra 400 012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9867016644 |
| Fax |
|
| Email |
moushmi792@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bai Jerbai Wadia Hospital for Children, Mumbai |
|
|
Primary Sponsor
|
| Name |
Bai Jerbai Wadia Hospital for Children |
| Address |
Bai Jerbai Wadia Hospital for Children, Acharya Donde Marg, Parel, Mumbai 400 012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Moushmi Hosalkar |
Nowrosjee Wadia Maternity Hospital |
Department of Neonatology, 1st floor NICU ,Nowrosjee wadia Maternity Hospital Acharya Donde Marg Parel Mumbai 400012
Mumbai
MAHARASHTRA |
9867016644
moushmi792@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Nowrosjee Wadia Maternity Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P779||Necrotizing enterocolitis in newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continued Feeds |
In this group, feeds will be continued during and around blood transfusion and will not be stopped. |
| Intervention |
Stopping Feeds |
In this group, feeds will be witheld for 4 hours before , during and after blood transfusion. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
4.00 Month(s) |
| Gender |
Both |
| Details |
All Neonates less than or equal to 34 weeks of Gestational age admitted to the NICU |
|
| ExclusionCriteria |
| Details |
-Parents opting out of the trial
-Contraindication to enteral feeds
-Has previously received enteral feeds during blood transfusion
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Necrotising Enterocolitis Post Packed Red Blood Cell Transfusion |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of NICU stay
Neonatal Mortality
Duration of Ventilation
Growth parameters
|
40 weeks of gestation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
08/01/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
All preterm neonates less than 34 weeks of gestation meeting the inclusion and exclusion criteria will be included in the study. This is a pilot randomised open label unblinded single centre study. The sample size is 50. The neonates will be divided into 2 study groups by a computer generated randomisation sequence. In the first group, the neonates will be kept nil per oral for 4 hours before, during and after Packed Red Blood Cell transfusion and in the second group enteral feeds will be continued before, after and throughout the transfusion. The neonates will be monitored for features of Necrotising enterocolitis occuring within 48 hours of Packed red cell transfusion using Modified Bell’s Staging.This study will help us to ascertain whether stopping feeds during and around packed red blood cell transfusion has any role in reducing the incidence of Transfsuion Associated Necrotising enterocolitis. The primary outcome is incidence of Necrotising enterocolitis post packed red cell transfsuion in preterm neonates. The secondary outcomes are neonatal moratlity, duration of NICU stay, duartion of ventilation and growth parameters. |