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Effect of early feed fortification on growth parameters in neonates born with birth weight less than 1500 grams

Efficacy of early versus standard feed fortification in neonates with less than 1500 grams birth weight on growth parameters: An open-label randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086478
Enrollment
198
Registered
2025-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: E46- Unspecified protein-calorie malnutrition

Interventions

Intervention1: Early Feed Fortification (EFF): Early feed fortification at feed volume of 40ml/kg/day with bovine based human milk fortifier (HMF) added to Mothers Own Milk (MOM). 1g HMF powder will b

Sponsors

IMS and SUM Hospital SOA University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All babies born less than 1500g birth weight and on incremental feeding up to 40ml/kg/day.

Exclusion criteria

Exclusion criteria: Major congenital abnormality (including known chromosomal abnormality), Major GI anomalies requiring surgery, Hemodynamic instability as defined by the need for more than one inotropic support prior to randomization, Antenatal Doppler changes such as Absent End Diastolic Flow/Reversal of End Diastolic Flow and babies born outside our hospital and admitted beyond 48hrs of life.

Design outcomes

Primary

MeasureTime frame
To assess, between EFF and SFF groups, for weight gain velocity in g/kg/day.Timepoint: At discharge from hospital

Secondary

MeasureTime frame
Length and head circumference gain and velocityTimepoint: At discharge;Weight, head circumference and length gain and velocitiesTimepoint: At 4 weeks and 3 months post natal age;Time to reach full feeds (150ml/kg/day)Timepoint: ;Time to regain birth weightTimepoint: ;Episodes of feeding intolerance with NPO in hoursTimepoint: At discharge;Weight, length and head circumference growth velocityTimepoint: Weekly till 4 weeks post natal age;NEC stage 2 & beyondTimepoint: At discharge or death;Incidence of extrauterine growth restrictionTimepoint: At discharge;Duration of parenteral nutritionTimepoint: At discharge;Culture positive sepsisTimepoint: At discharge;Duration of Hospital stay (in days)Timepoint: At discharge;All cause mortalityTimepoint:

Countries

India

Contacts

Public ContactDr Neha Goudar

IMS and SUM Hospital (SOA University)

debasishnanda@soa.ac.in9861422685

Outcome results

None listed

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