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Role of early human milk fortification in preterm very low birth weight neonates

Comparison of Early Versus Standard Fortification of Human Milk in Preterm Very Low Birth Weight Neonates â?? A Randomised Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017361
Enrollment
72
Registered
2019-01-31
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: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Addition of Human milk fortifier to Human milk at 40ml/kg/day: After meeting the inclusion criteria, addition of Human milk fortifier(Nestle HMF) to human milk at 40ml/kg/day when the n

Sponsors

Ankura hospital for women and children
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: They are born below 32 weeksâ?? Gestational age and weighing below 1500 gramsâ?? birth weight, AND Tolerating at least 40 mL/kg per day of enteral feeding by 7 daysâ?? postnatal age

Exclusion criteria

Exclusion criteria: Preterm infants receiving formula milk to provide >25% of total enteral feed volume Neonates with major congenital malformations Neonates with abnormal antenatal umbilical artery doppler (Increased Resistance, Absent End Diastolic Flow, Reversal of End Diastolic Flow)

Design outcomes

Primary

MeasureTime frame
Time taken to regain birth weight in days in early fortification versus standard fortification group Timepoint: Time taken in days from birth to regain birth weight

Secondary

MeasureTime frame
1. Weight gain (in grams/kg/day) from the time of enrolment until 34 weeksâ?? post menstrual age (PMA) 2. Incidence of Stage II and Stage III Necrotising enterocolitis. 3.Head growth (cms/week) 4.Length gain(cms/week) 5. Blood urea nitrogen levels,Serum calcium, phosphorous and alkaline phosphatase (ALP) levels at 34 weeksâ?? post menstrual age (PMA) as a measure of bone mineral status. 6.Weekly weight gain velocity, Head growth velocity from the time of enrolment to 34weeks PMA.Timepoint: Weekly from birth to 34 weeks post menstrual age (PMA)

Countries

India

Contacts

Public ContactAparna C

Ankura hospital for women and children

appubanu@gmail.com7708427060

Outcome results

None listed

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