| CTRI Number |
CTRI/2025/07/090829 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Slow vs Fast Tube Feeding in Premature Babies Weighing Less Than 1250 Grams to See Which Method Improves Feeding Tolerance |
|
Scientific Title of Study
|
A Study Comparing Semi-Continuous and Bolus Feeding in Premature Babies Weighing Less Than 1250 Grams to See Which Method Improves Feeding Tolerance |
| 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 Neeraj Kumar |
| Designation |
DrNB (Neonatology) |
| Affiliation |
Madhukar Rainbow Childrens Hospital |
| Address |
Flat No. 142, Balco Apartment, IP Extension
Dept of Neonatology, Madhukar Rainbow Childrens Hospital, FC-29 5, Geetanjali Marg, near Malviya Nagar, Block A, Shivalik Colony, Malviya Nagar, Delhi, New Delhi, Delhi 110017
South
DELHI
110092
India |
| Phone |
9555105874 |
| Fax |
|
| Email |
drniraj.kr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Batra |
| Designation |
Senior Consultant |
| Affiliation |
Madhukar Rainbow Childrens Hospital |
| Address |
Madhukar Rainbow Children Hospital, FC-29 5, Geetanjali Marg, near Malviya Nagar, Block A, Shivalik Colony, Malviya Nagar, Delhi, New Delhi, Delhi
South
DELHI
110017
India |
| Phone |
9650015236 |
| Fax |
|
| Email |
drbatra77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen Prakash Gupta |
| Designation |
Senior Consultant |
| Affiliation |
Madhukar Rainbow Childrens Hospital |
| Address |
Madhukar Rainbow Children Hospital, FC-29 5, Geetanjali Marg, near Malviya Nagar, Block A, Shivalik Colony, Malviya Nagar, Delhi, New Delhi, Delhi
South
DELHI
110017
India |
| Phone |
9811758133 |
| Fax |
|
| Email |
drgupta.naveen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madhukar Rainbow Children Hospital, FC-29 5, Geetanjali Marg, near Malviya Nagar, Block A, Shivalik Colony, Malviya Nagar, Delhi, New Delhi, Delhi 110017, India |
|
|
Primary Sponsor
|
| Name |
Madhukar Rainbow Children Hospital |
| Address |
FC-29 5, Geetanjali Marg, near Malviya Nagar, Block A, Shivalik Colony, Malviya Nagar, Delhi, New Delhi, Delhi 110017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Anil Batra |
Madhukar Rainbow Children Hospital |
FC-29 5, Geetanjali Marg, near Malviya Nagar, Block A, Shivalik Colony, Malviya Nagar, Delhi, New Delhi, Delhi 110017
South
DELHI |
9650015236
drbatra77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Madhukar Rainbow Childrens Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Very Low birth weight |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bolus Tube feeds |
Tube feeds will be given via bolus under the effect of gravity |
| Intervention |
Semi Continuous Tube Feeds |
Tube feeds will be given via Orogastric/Nasogastric tube over 30 min through an infusion pump |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Infants with a birth weight of less than 1250 grams who are hemodynamically stable and whose parents have provided consent were included in the study. |
|
| ExclusionCriteria |
| Details |
Infants with congenital malformations, chromosomal anomalies, shock requiring inotropic support, or without parental consent were excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to reach full enteral feeds—was the day on which the infant tolerated the target feeding volume without interruption, measured from the start of enteral feeding. |
Outcome will be assessed at 4 weeks from start date. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The outcomes assessed will include the number of NPO days, events necessitating discontinuation of feeds (such as apnea, bradycardia, or vomiting), daily weight gain, & the occurrence of necrotizing enterocolitis (NEC). |
Outcome will be assessed based on time to regain birth weight on daily basis till 4 to 8 weeks. |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
25/07/2025 |
| 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="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
|
With advances in neonatal care survival of neonates has increased .one of the indications for admission in nicu is prematurity and low birth weight. Babies are given either semicontinuous gastric infusion or intermittent gastric bolus as there is no coordination in sucking and swallowing ,a requirement for oral feeding. There are limited studies related to which method leads to early attainment of full feeds and better weight gain.so a study is planned to compare semicontinuous versus bolus feeding and its outcome in form of attainment of full feeds, weight gain and feed intolerance. |