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Fortification of expressed breast milk with preterm formula Vs commercial fortifiers in preterm very low birth weight infants

Fortification of Expressed breast milk with preterm formula powder vs human milk fortifier in preterm (28 - 34 wks POG) very low birth weight neonates : A randomized non inferiority trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010593
Enrollment
124
Registered
2017-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Preterm (28 - 34 weeks POG) Very low birth weight neonates Health Condition 2: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Preterm formula powder: Dexolac Special care Control Intervention1: Human milk fortifier: PreNAN

Sponsors

All India Institute of Medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Preterm neonates born between 28 and 34 weeks of gestation 2.Birth weight less than 1500 g 3.Accepting oral feeds of at least 100ml/kg/day 4.Amount of EBM, as a proportion of total daily milk intake, 75% or greater at enrollment.

Exclusion criteria

Exclusion criteria: Major congenital anomalies

Design outcomes

Primary

MeasureTime frame
Rate of weight gain from the time of fortification till hospital dischargeTimepoint: Day 7,14,21,28 or till discharge, whichever is earlier—

Secondary

MeasureTime frame
Incidence of morbidities like late metabolic acidosis, necrotizing enterocolitis, osteopenia of prematurity, anemia requiring blood transfusionsTimepoint: Day 1,2,3 till hospital discharge and at 40 wks PMA;Proportion of babies found to be growth restricted at term gestationTimepoint: At 40 wks PMA;Proportion of infants needing crossing over to other armTimepoint: Day 1,2,3 till hospital discharge;Weekly rate of gain in length and head circumferenceTimepoint: Day 7,14,21,28 or at discharge, whichever is earlier—

Countries

India

Contacts

Public ContactArunambika C

All India Institute of Medical Sciences

jeevasankar@gmail.com9791239124

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026