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Comparison of Efficacy and safety between human milk being fortified when very low birth weight baby reaches enteral feed of 100mL/kg/day and when the baby reaches enteral feed of 60mL/kg/day

Efficacy and safety of early fortification of human milk as compared to standard fortification in very low birth weight babies ââ?¬â?? an open labelled parallel arm Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045530
Enrollment
120
Registered
2022-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: P00-P96- Certain conditions originating in the perinatal period

Interventions

Intervention1: Early fortification: Fortification of human milk, when the baby reaches enteral feed volume of 60mL/kg/day, and continued till the baby reaches weight of 2kg or discharge, whichever is

Sponsors

Institute Human milk fortifier is basic newborn care it will be funded by institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants with birth weight (BW) less than 1500g with gestational age less than 34weeks, who are on breast-milk.

Exclusion criteria

Exclusion criteria: 1. Those infants who die or are expected to die within 72 hours 2. Those who were diagnosed with major congenital or chromosomal abnormalities 3. Babies who are on mixed feeds or formula feeding at the time of enrollment.

Design outcomes

Primary

MeasureTime frame
rate of weight gain (g/kg/day), time to regain birth weight (days), linear growth (cm/week) and increase in head circumference (cm/week)Timepoint: Till discharge from NICU—

Secondary

MeasureTime frame
biochemical parameters reflecting the nutritional status of the neonateTimepoint: every 2 weekly till discharge;cost effectiveness of the interventionTimepoint: Till discharge from NICU;incidence of feed intolerance and necrotizing enterocolitis (NEC)Timepoint: Till discharge from NICU;the rate of weight gain (g/kg/day), linear growth (cm/week) and increase in head circumference (cm/week)Timepoint: at 6th week of gestationally corrected age—

Countries

India

Contacts

Public ContactHarinisri Murali Ramji

All India Institute of Medical Science, Raipur

triptyn@aiimsraipur.edu.in9826130218

Outcome results

None listed

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