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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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