| CTRI Number |
CTRI/2025/08/092744 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Human milk fortification] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of adding milk supplement to mothers milk after discharge from the hospital on the brain development in preterm infants |
|
Scientific Title of Study
|
Long term neurodevelopmental outcome in Very Low Birth Weight (VLBW) preterm infants receiving post-discharge fortification in a resource limited setting: A Randomized Control 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 |
Anitha Haribalakrishna |
| Designation |
Associate Professor and Head of Department, Neonatology |
| Affiliation |
Seth GS Medical College and King Edward Memorial Hospital |
| Address |
Department of Neonatology, Seth GS Medical College and KEM Hospital, New building, 10th floor, acharya Donde Marg,Parel Mumbai, Maharashtra
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, Neonatology |
| Affiliation |
Seth GS Medical College and King Edward Memorial Hospital |
| Address |
Department of Neonatology, Seth GS Medical College and KEM Hospital, New building, 10th floor, acharya Donde Marg,Parel Mumbai, Maharashtra
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, Neonatology |
| Affiliation |
Seth GS Medical College and King Edward Memorial Hospital |
| Address |
Department of Neonatology, Seth GS Medical College and KEM Hospital, New building, 10th floor, acharya Donde Marg,Parel Mumbai, Maharashtra
Mumbai MAHARASHTRA 400012 India |
| Phone |
9769660870 |
| Fax |
|
| Email |
ani.gem81@gmail.com |
|
|
Source of Monetary or Material Support
|
| KEM Hospital, Acharya Donde Marg, Pael, Mumbai, 400012 |
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Neonatology, New building, 10th floor, Seth GS Medical College and KEM Hospital, acharya Donde Marg, Parel, Mumbai, 400012 |
| 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 |
| Anitha Haribalakrishna |
Seth GS Medical College and KEM Hospital |
New building, 10th floor, Department of Neonatology, KEM Hospital, Parel, MUmbai, 400012 Mumbai MAHARASHTRA |
9769660870
ani.gem81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bovine-based Human Milk Fortifier (Lactodex powder, 1 g sachet, Raptokas Brett & Co Ltd, India with composition of 0.27g protein,0.04g fat,0.49g carbohydrates, 15.8mg Calcium, 7.9mg phosphorus,3.37 K Cal) will be continued post discharge |
(Human Milk Fortification group) where multicomponent bovine based human milk fortifier (HMF) will be continued post- discharge till the infant reaches 1800 grams which will be approximately 6 weeks. The compliance to HMF will be ensured by asking parents to follow up in our OPD with the empty HMF sachets and the numbers will be verified. Infants will be followed up till one year of age. |
| Comparator Agent |
Control/Comparator group |
HMF will be stopped at discharge and infants will be discharged on calcium, iron, and vitamin D supplementation according to their weight and will be followed up till one year of age |
|
|
Inclusion Criteria
|
| Age From |
7.00 Day(s) |
| Age To |
99.00 Day(s) |
| Gender |
Both |
| Details |
Inborn neonates less than 37 completed weeks of gestation with birth weight less than 1500 grams who were on either mother’s milk or pasteurized donor human milk supplemented with bovine-derived HMF will be enrolled in the study within 48 hours before discharge. |
|
| ExclusionCriteria |
| Details |
Preterm infants who do not tolerate HMF, infants with severe intraventricular hemorrhage (IVH), posthemorrhagic ventricular dilatation (PHVD), meningitis, surgical conditions, congenital anomalies and cyanotic congenital heart disease will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neurodevelopmental outcome at 12 months corrected age in very low birth weight preterm infants receiving post discharge fortification and those receiving unfortified feeds after discharge. |
12 months corrected age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Gain in weight, length and head circumference till 40 weeks postmenstrual age |
40 weeks gestation, 3,6,9 and 12 months of age |
| Incidence of feed intolerance post discharge |
Any time after discharge while infant is still on human milk fortification |
| Anemia of prematurity |
within 3 months post discharge |
| Retinopathy of prematurity |
3 weeks till 12 weeks |
| Mortality |
Any time after discharge while infant is still on human milk fortification |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
07/09/2025 |
| 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
|
This prospective randomized controlled trial aims to study the neurodevelopmental outcomes of very low birth weight preterm infants receiving post-discharge human milk fortification versus those receiving standard unfortified feeds. Preterm VLBW infants often experience growth faltering and extrauterine growth restriction despite improved NICU survival rates. While human milk fortification during NICU stay is standard practice, most centers discontinue fortification at discharge, potentially compromising post-discharge growth and development. The 18-month study will be conducted at KEM Hospital’s Level 3 NICU, enrolling 200 inborn preterm infants weighing less than 1500 grams at 37 weeks gestation or less. Participants will be randomized into two groups namely intervention group receiving continued HMF supplementation until reaching 1800 grams weight, and control group receiving standard calcium, iron, and vitamin D supplementation post-discharge. Primary Outcome is to compare neurodevelopmental outcomes at 12 months corrected age using Bayley Scales of Infant and Toddler Development 4th edition between both groups. Secondary Outcomes are to Assess weight gain, length and head circumference growth until 40 weeks postmenstrual age, feed intolerance incidence, mortality, anemia of prematurity, retinopathy of prematurity, and osteopenia of prematurity. Methodology will be that Infants will receive bovine-based HMF at 1 gram per 25ml of human milk. Follow-up includes twice-weekly visits until 1.5kg, then bi-weekly until 1.8kg, with neuromotor assessments at term, 3, 6, 9, and 12 months corrected age. Sample size of 174 infants calculated with 80% power, accounting for 15% loss to follow-up, totaling 200 participants. Analysis will follow intention-to-treat principle using appropriate statistical tests. |