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A study comparing two types of powders (plant based versus cow based) which are meant for increasing the proteins and calories of mothers milk in babies who are born prematurely

Bovine derived versus plant based human milk fortification in preterm infants of less than 30 weeks gestation An open labelled multi-center randomized controlled trail - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075823
Enrollment
100
Registered
2024-10-24
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 based human milk fortifier: Plant based human milk fortifier 1 gram will be mixed in every 25 ml of mothers own milk or pasteurised donor human milk. fortification will be done ti

Sponsors

Nikhil Kumar M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: preterm neonates who are started on mothers own milk or pasteurised donor human milk within 48hours of life and total parenteral nutrition within 6 hours of life.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
time to reach enteral feed volume of 180ml per kg per day, rate of weight gain, head circumference increment and length incrementTimepoint: at discharge and at 40weeks PMA.

Secondary

MeasureTime frame
Incidence of feed intolerance defined as necessity to keep the neonate nil by mouth for at least 1 day NEC stage more than or equal to 2 Modified Bellsâ?? staging Combined outcome of NEC stage more than or equal to 2 or mortality All-cause mortality Probable sepsis with more than or equal to 2 serum parameters CRP more than 10mg per L, TLC less than 5000 or more than 25000cells per mm3, ANC as per charts or Procalcitonin more than 0.1ng per ml Blood culture proven sepsis beyond 72hours BPD defined as oxygen requirement or any other form of respiratory support at 36 weeks ROP requiring intervention. Osteopenia of prematurity defined as impaired bone mineralization with ALP more than 900IU per L, Serum Phosphorus less than 5.5mg per dl Extra uterine growth restriction defined as to an inadequate growth that occurs during hospitalization weight less than 10th centile at 36weeks PMA.Timepoint: enteral feeds started within 48 hours of life and TPN started within 6 hours of life.

Countries

India

Contacts

Public ContactNikhil Kumar M

Ankura Hospital for Women and Children

19.vira@gmail.com7204175425

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026