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If preterm milk is not inferior to HMF as a preterm human milk fortifier

Human Milk Fortifier VS Preterm milk for fortification of Preterm Human Milk. A Non Inferiority Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070683
Enrollment
116
Registered
2024-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Health Condition 1: R50-R69- General symptoms and signs

Interventions

Intervention1: Preterm formula milk.: Preterm formula milk 1gm in 20 ml expressed breast milk every feed till baby is discharged Control Intervention1: Preterm milk.: Preterm milk Control Intervention

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants with a gestational age less than 34 weeks admitted to the neonatal intensive care unit (NICU). Receiving EBM of 100ml/kg/day. Give consent to be included in the study.

Exclusion criteria

Exclusion criteria: Preterm with major congenital anomalies Neonates not receiving preterm human milk (LESS THAN 75%). Preterm who is on Mechanical ventilation Neonates requiring surgery.

Design outcomes

Primary

MeasureTime frame
To know the efficacy of fortifying preterm human milk with Preterm Formula Milk and Human Milk Fortifier in terms of time achieved to attain birth weight.Timepoint: Till discharge—

Secondary

MeasureTime frame
To assess the head circumference and length To assess the complications like feed intolerance, necrotizing enterocolitis.Timepoint: till discharge—

Countries

India

Contacts

Public Contactammar haider

GMCH, aurangabad

dramolkj@yahoo.com8658222360

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026