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CTRI Number  CTRI/2025/07/089932 [Registered on: 01/07/2025] Trial Registered Prospectively
Last Modified On: 29/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nutritional / Dietary Supplement]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Helping low birth weight preterm babies grow: comparing two nutrient mixes added to mother’s milk 
Scientific Title of Study   Human Milk Fortifier Vs Preterm formula milk for fortification of Preterm Human Milk. A Non Inferiority Randomized Controlled Trial (PREMFORT STUDY) 
Trial Acronym  PREMFORT (PREMature infant FORTification trial) 
Secondary IDs if Any  
Secondary ID  Identifier 
PHARMA/IEC-GMCA/202/2024  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ammar Haider 
Designation  DM Resident 
Affiliation  GMCH, Chhatrapati sambhajinagar 
Address  Senior Resident, Department of NeonatologyGovernment Medical College, Ch. Sambhajinagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  8658222360  
Fax    
Email  haider263@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amol Joshi 
Designation  Associate Professor 
Affiliation  GMCH, Chhatrapati sambhajinagar 
Address  Department of NeonatologyGovernment Medical College, Ch. Sambhajinagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  9823900641  
Fax    
Email  dramolkj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amol Joshi 
Designation  Associate Professor 
Affiliation  GMCH, Chhatrapati sambhajinagar 
Address  Department of NeonatologyGovernment Medical College, Ch. Sambhajinagar


MAHARASHTRA
431001
India 
Phone  9823900641  
Fax    
Email  dramolkj@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DR Ammar Haider 
Address  Dr. Ammar Haider Senior Resident, Department of Neonatology Government Medical College, Ch. Sambhajinagar, Maharashtra 431001 
Type of Sponsor  Other [self] 
 
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 
Dr Ammar Haider  Government Medical College, Chhatrapati Sambhajinagar  Government Medical College, Department of Neonatology, Chhatrapati Sambhajinagar, Maharashtra, India
Aurangabad
MAHARASHTRA 		 8658222360

haider263@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government Medical College, Aurangabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Commercial Human Milk Fortifier   To add 1 sachet (1gm) in 25ml Preterm Human Milk 
Intervention  Preterm Formula Powder  To add 1gm in 25ml Preterm Human Milk 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Preterm neonates with gestational age less than 34 weeks,
Birth weight less than 1500 grams (Very Low Birth Weight),
Receiving at least 100 mL/kg/day of expressed breast milk at the time of enrollment,
Written informed consent obtained from parent or legal guardian. 
 
ExclusionCriteria 
Details  Presence of major congenital anomalies,
Neonates requiring surgery during NICU stay,
Infants not receiving mother’s own milk or receiving less than 75% of feeds as expressed breast milk

Neonates on mechanical ventilation at the time of enrollment

 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean weight gain (g/kg/day)  At 40 weeks postmenstrual age or discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Length gain (cm/week)  Weekly until discharge 
Head circumference gain (cm/week)  Weekly until discharge 
Feed intolerance  During hospital stay 
Late onset sepsis  After 72 hours of life 
Anemia requiring transfusion  During hospital stay 
Hemodynamically significant PDA  During hospital stay 
ROP requiring laser therapy  During hospital stay 
Moderate to severe BPD  At 36 weeks postmenstrual age 
IVH more than grade 2  During hospital stay 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
Final Enrollment numbers achieved (Total)= "164"
Final Enrollment numbers achieved (India)="164" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/07/2025 
Date of Study Completion (India) 20/08/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/08/2026 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [haider263@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a single center randomized open label non inferiority clinical trial comparing the effect of preterm formula and human milk fortifier for fortifying expressed breast milk in very low birth weight preterm infants less than 34 weeks gestation and less than 1500 grams. Infants receiving at least 100 mL per kg per day of expressed breast milk will be randomized into two groups. One group will receive preterm formula powder at 1 gram per 25 mL of expressed breast milk and the other group will receive commercial human milk fortifier at 1 gram per 25 mL. The primary outcome is mean weight gain in grams per kg per day until 40 weeks postmenstrual age or discharge. Secondary outcomes include weekly gain in length and head circumference and incidence of feed intolerance necrotizing enterocolitis late onset sepsis anemia requiring transfusion patent ductus arteriosus retinopathy of prematurity bronchopulmonary dysplasia and intraventricular hemorrhage. A total of 164 infants will be enrolled. Study duration is 12 months. 
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