Comparing amino acid based and bovine milk based human milk fortifiers for growth in babies with very low birth: A Clinical Trial

Comparison of efficacy of amino acid based human milk fortifier versus bovine milk derived human milk fortifier in very low birth weight neonates: A single Centre open label randomized controlled trial - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/076032

Enrollment

110

Registered

2024-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P071- Other low birth weight newborn

Interventions

Intervention1: Amino acid based human milk fortifier (AA-HMF): Babies will be started on amino acid based human milk fortifier in ratio of 1 HMF sachet in 25 ML of milk or will be added in proportiona

Eligibility

Inclusion criteria

Inclusion criteria: 1.Babies with birth weight 500 to (Explanation-when baby fulfill 1st criterion then baby will receive following routine care) Step 1- An intravenous glucose infusion/TPN/PPN 80 mL/kg/day will be started during the first hours of life. Step 2- Progressive enteral feeding with initial volume of 30 ml/kg/day will be started in babies as per motherâ??s own milk availability as per unit protocol 2.Babies with milk intake of at least 100 ml/kg/day. (Explanation: when baby reach feed volume of 100 ml/kg/day-fortification will be started) 3.Maternal intent to provide breast milk. (Explanation: Fortification is only for the breast milk)

Exclusion criteria

Exclusion criteria: 1.Parents and guardians unwilling to provide consent for the study. 2.Major congenital malformation. 3.Necrotising enterocolitis. 4.Complete unavailability of motherâ??s own milk. 5.Motherâ??s milk is contraindicated.

Design outcomes

Primary

Measure	Time frame
Rate of weight gain (g/kg/day) till 1800 grams of weight achieved.Timepoint: Daily weight will be checked till baby attain 1800 gram weight	—

Secondary

Measure	Time frame
1. Time taken to reach weight of 1800 grams (days) 2. Length gain (cm/week) till 1800 grams. 3. Head circumference gain (cm/week) till 1800 grams 4. Laboratory parameters Laboratory Parameters: 1. Blood Urea Nitrogen â?? Baseline and once weekly till 1800 grams of weight achieved. 2. Total serum proteins, Serum Albumin Levels â?? Baseline and once weekly till 1800 grams of weight achieved. 3. Ionic Calcium, Serum Phosphorus, Serum Alkaline phosphatase -Baseline and once weekly till 1800 grams of weight achieved. 4. Serum Sodium and serum potassium- Baseline and once weekly till 1800 grams of weight achieved. 5. Vitamin d level- Baseline and at 1800 grams of weight. Timepoint: 1. Time(days taken to achieve weight of 1800 grams) 2. Weekly length measurement till 1800 gram 3. Weekly head circumference measurement. Laboratory parameters as described Baseline(After enrollment in trial before starting intervention), weekly and at the time of attainment of 1800 grams of weight.	—

Measure

Time frame

1. Time taken to reach weight of 1800 grams (days) 2. Length gain (cm/week) till 1800 grams. 3. Head circumference gain (cm/week) till 1800 grams 4. Laboratory parameters Laboratory Parameters: 1. Blood Urea Nitrogen â?? Baseline and once weekly till 1800 grams of weight achieved. 2. Total serum proteins, Serum Albumin Levels â?? Baseline and once weekly till 1800 grams of weight achieved. 3. Ionic Calcium, Serum Phosphorus, Serum Alkaline phosphatase -Baseline and once weekly till 1800 grams of weight achieved. 4. Serum Sodium and serum potassium- Baseline and once weekly till 1800 grams of weight achieved. 5. Vitamin d level- Baseline and at 1800 grams of weight. Timepoint: 1. Time(days taken to achieve weight of 1800 grams) 2. Weekly length measurement till 1800 gram 3. Weekly head circumference measurement. Laboratory parameters as described Baseline(After enrollment in trial before starting intervention), weekly and at the time of attainment of 1800 grams of weight.

—

Countries

India

Contacts

Public ContactDr Ankit jaisinh Chauhan

All India Institute of Medical Sciences Nagpur

ankitchauhan@aiimsnagpur.edu.in9643900490

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026