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Comparison of supplementation of preterm versus term donor pooled human milk on growth of very low birth weight neonates

Supplementation of mother�s milk with term versus preterm donor human milk and its effect on the growth of very low birth weight neonates-A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023569
Enrollment
100
Registered
2020-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: P76-P78- Digestive system disorders of newborn

Interventions

Intervention1: Donor preterm human milk supplementation: Patients randomized to this group will receive pooled preterm DHM when MOM will not be available or insufficient in quantity. No baby will be d

Sponsors

Government Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Very low birth babies (birth weight <1500 grams)

Exclusion criteria

Exclusion criteria: 1. Babies born with major congenital malformation 2. Babies who had already developed NEC IIa or above before enrollment 3. Babies born to retrovirus positive mother 4. Babies born at gestation 5. Galactosemia or other contraindication to human milk

Design outcomes

Primary

MeasureTime frame
Days to regain birth weight in VLBW babies received pooled preterm DHM and pooled term DHMTimepoint: At discharge or at 40 weeks post menstrual age

Secondary

MeasureTime frame
Duration of parenteral nutrition use (days)Timepoint: Till discharge;Episodes of feeding intoleranceTimepoint: Till discharge;Incidence of necrotising enterocolitis IIa or moreTimepoint: Till discharge;Rate of head circumference gain in cm/weekTimepoint: At discharge or at 40 weeks post menstrual age;Rate of length gain in cm/weekTimepoint: At discharge or at 40 weeks post menstrual age;Rate of weight gain in gm/kg/dayTimepoint: At discharge or at 40 weeks post menstrual age;Time to achieve full feed (day-1 of 120 ml/kg/day if tolerate for 3 consecutive days)Timepoint: Time to achieve full feed;Z Score of weight, height and head circumferenceTimepoint: At 40 weeks of post menstrual age

Countries

India

Contacts

Public ContactDr Vimlesh Soni

Government Medical College and Hospital, Chandigarh

dr.sukshamj@gmail.com9988901596

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026