| CTRI Number |
CTRI/2025/02/081432 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the effects of adding extra nutrients to breast milk early versus later on the growth of premature babies weighing less than 1500 grams. |
|
Scientific Title of Study
|
Effect of Early Fortification Versus Delayed Fortification of Human Milk on Anthropometric Parameters in Very Low birth Weight Infants: A Randomized Controlled Trial |
| 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 Sushil Kumar Choudhary |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical sciences, Jodhpur |
| Address |
Department of Neonatology, All India Institute of Medical sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9013355932 |
| Fax |
|
| Email |
drsusil85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Kumar Choudhary |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical sciences, Jodhpur |
| Address |
Department of Neonatology,
All India Institute of Medical sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9013355932 |
| Fax |
|
| Email |
drsusil85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anilkumar J S |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical sciences, Jodhpur |
| Address |
Department of Neonatology,
All India Institute of Medical sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9008515133 |
| Fax |
|
| Email |
anilkumarjs1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical sciences, Jodhpur
Pincode- 342005
India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical sciences Jodhpur |
| Address |
All India Institute of Medical sciences, Jodhpur
Pincode 342005
India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anilkumar J S |
Neonatal intensive care unit |
Tertiary care hospital based study. The Department of Neonatology All India Institute of Medical sciences, Jodhpur
Jodhpur
RAJASTHAN |
9008515133
anilkumarjs1994@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Instituional ethics committee All India Institute of Medical sciences, Jodhpur |
Approved |
| Instituional ethics committee All India Institute of Medical sciences, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P969||Condition originating in the perinatal period, unspecified, (2) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fortification of human milk |
This study aimed to compare early fortification (feed volume 80ml/kg/day) versus delayed fortification (120 ml/kg/day).
|
| Comparator Agent |
FORTIFICATION OF HUMAN MILK |
THIS STUDY AIMED TO COMPARE EARLY FORTIFICATION (FEED VOLUME 80ML/KG/DAY) WITH DALAYED FORIFICTION (120 ML/KG/DAY). |
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All inborn newborn admitted in NICU with Birth weight less than 1500 grams
Gestation more than or equal to 26 weeks |
|
| ExclusionCriteria |
| Details |
Major congenital anomalies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to regain birth weight (in days) and subsequent rate of weight gain (gram/kg/day) at 4 weeks of postnatal age or discharge whichever is earlier |
Time to regain birth weight (in days) and subsequent rate of weight gain (gram/kg/day) at 4 weeks of postnatal age or discharge whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| increase in head circumference (cm/week) and length (cm/week) till discharge. |
till discharge |
Correlation between total protein intake and time to regain birth weight in days , weight
gain velocity , head circumference cm/ week, length cm /week. |
till discharge |
| Incidence of NEC stage 2 or more as per modified Bell’s stage. |
till discharge |
| Feed intolerance incidence |
till discharge |
| All cause mortality(In hospital) |
till discharge |
Incidence of extrauterine growth restriction at discharge (number of infants with weight <
10th percentile for the index population) |
till discharge |
| Incidence of ROP requiring treatment |
Till discharge |
| BPD incidence |
till discharge |
|
Target Sample Size
Modification(s)
|
Total Sample Size="98"
Sample Size from India="98"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/03/2025 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The current study aims to examine the effects of early fortification (initiating at 80 ml/kg/day) versus late fortification (initiating at 120 ml/kg/day) on the time taken to regain birth weight in preterm infants and weight gain velocity pattern following that along with head circumference and length increments. Understanding this could enhance nutritional protocols in the NICU, supporting the growth and development of this vulnerable population.
|