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Comparing the growth of very low birth babies who are fed with breast milk with or without added milk powder formula

A randomized controlled trial comparing the effect of fortification of human milk with an infant formula powder on the growth of very low birth weight babies - The FOAM Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/11/004149
Enrollment
170
Registered
2013-11-19
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 babies with less than 34 weeks gestation and birth weight less than 1500 grams

Interventions

Intervention1: fortification of expressed breast milk with infant formula: Expressed breast milk fed to preterm babies once they reach full volume feeds that is equal or greater than 150ml/kg/day will

Sponsors

Fluid research fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Preterm babies, born between 27 to 150ml/kg)

Exclusion criteria

Exclusion criteria: 1. Lack of consent 2. Neonates with major congenital/ chromosomal anomalies (An anatomic abnormality severe enough to reduce normal life expectancy or compromise normal function) 3. Necrotising enterocolitis stage 2 and 3 4. Babies in whom breast milk is contra indicated

Design outcomes

Primary

MeasureTime frame
Weight gain in g/kg/dayTimepoint: From the day of recruitment in to the study until the baby reaches 1800 gms weight

Secondary

MeasureTime frame
1. Linear growth- rate of length gain in cm/week 2. Head circumference gain in cm/wk 3. Co-morbidities- feed intolerance, sepsis and Necrotizing enterocolitis 4. Biochemical markers : blood urea, serum albumin and prealbumin 4. length of hospital stay Timepoint: From the day of recruitment in to the study until the baby reaches 1800 gms weight

Countries

India

Contacts

Public ContactVijay Gupta

CMC Hospital

niranjan@cmcvellore.ac.in04162283311

Outcome results

None listed

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