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A study comparing two types of powders (plant source versus cow source) which are usually added to mothers milk for increasing the nutrient and energy content in babies who are born before the expected date of delivery.

Bovine derived versus plant derived human milk fortification in preterm infants born at less than 34 weeks gestation an open labelled randomized controlled trail - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089133
Enrollment
100
Registered
2025-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

None listed

Interventions

Intervention1: Plant derived human milk fortifier: Neonates born less than 34 weeks will be randomized to either intervention group or comparator group. Neonates in intervention group will be given 1

Sponsors

Nikhil Kumar M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates born less than 34 weeks gestation who are started on mothers own milk or pasteurized donor human milk within 48 hours of life or total parenteral nutrition within the first 6 hours of life.

Exclusion criteria

Exclusion criteria: 1. Preterm neonates with gross congenital malformations. 2. Preterm neonates whose caretakers refuse to give consent.

Design outcomes

Primary

MeasureTime frame
1. Time to reach enteral feed volume of 180ml/kg/day.(gm/kg/week), head circumference increment (cm/week) and length increment (cm/week) from the time of enrolment until discharge from the hospital or 40weeks PMA, whichever is later.Timepoint: 40 weeks post menstrual age—

Secondary

MeasureTime frame
1. Incidence of feed intolerance (defined as necessity to keep the neonate nil by mouth for at least 1 day) Timepoint: 40 weeks PMA;NEC stage more than or equal to 2 (Modified Bells staging)Timepoint: 40 weeks PMA;Combined outcome of NEC stage more than or equal to 2 or mortalityTimepoint: 40 weeks PMA;All-cause mortalityTimepoint: 40 weeks PMA;Probable sepsis with more than or equal to 2 serum parameters (CRP more than 10mg/L, TLC less than 5000 or more than 25000cells/mm3, ANC less than 1800/mm3)Timepoint: 40 weeks PMA;Blood culture proven sepsis beyond 72 hoursTimepoint: 40 weeks PMA;Bronchopulmonary dysplasia (BPD) (defined as oxygen requirement or any other form of respiratory support at 36 weeks PMA)Timepoint: 36 weeks PMA;Retinopathy of prematurity (ROP) requiring interventionTimepoint: 40 weeks PMA;Osteopenia of prematurity defined as impaired bone mineralizationTimepoint: 40 weeks PMA;Extra uterine growth restriction defined as weight less than 10th centile at 36 weeks PMATimepoint: 36 weeks PMA—

Countries

India

Contacts

Public ContactNikhil Kumar M

Ankura Hospital For Women and Children

19.vira@gmail.com8130402185

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 6, 2026