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slow vs fast feeds with late vs early milk fortification in preterms

slow enteral feed advancement with late human milk fortification vs fast enteral feed advancement with early human milk fortification in preterm infants more than 30 weeks gestation- a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043571
Enrollment
90
Registered
2022-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Conditions

None listed

Interventions

Intervention1: human milk fortification early versus late: Slow advancement with late fortification: infants in this group will be started feeds at @ 20ml/kg/day and advanced at the same rate to 140ml

Sponsors

Dr Anitha Haribalakrishna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: any preterm infant > 30 weeks gestation with birth weight between 1 to 1.5 Kg will be eligible

Exclusion criteria

Exclusion criteria: 1.preterm with congenital anomalies 2. those with respiratory distress at the time of enrollment 3. those on inotropic support during feed initiation 4. severe birth asphyxia 5. requirement of mechanical ventilation 6. surgical neonates 7. absent or reverse end diastolic flow in antenatal Doppler

Design outcomes

Primary

MeasureTime frame
Time to regain birth weight.Timepoint: baseline, 2 weeks and 4 weeks

Secondary

MeasureTime frame
â?¢ time to reach full enteral feeds: a feed volume of 140ml/kg/day â?¢ duration of intravenous fluids â?¢ duration of hospital stay â?¢ incidence of NEC: as per Bellâ??s stage â?¥2 â?¢ incidence of feed intolerance: increase in abdominal girth by 2cm, altered aspirates 50% feed volume â?¢ incidence of sepsis: Late onset sepsis if any two sepsis screen parameters are positive â?¢ mortality. Timepoint: baseline, 2 weeks and 4 weeks

Countries

India

Contacts

Public ContactDr Anitha Haribalakrishna

Seth GS Medical College and KEM Hospital

ani.gem81@gmail.com02224107035

Outcome results

None listed

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