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Post discharge fortification of human milk

Clinical outcomes related to human milk fortification in very low birth weight preterm infants post discharge- a prospective observational study - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069958
Enrollment
126
Registered
2024-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: O602- Term delivery with preterm labor

Interventions

Intervention1: Post discharge fortification group: where HMF was continued post discharge till infant reached 1.8 Kg which will be 4 to 6 weeks after dischrge Control Intervention1: control group : HM

Sponsors

Seth GS Medical College and KEM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inborn neonates = 37 completed weeks of gestation with birth weight < 1.5 Kg who were on either mother’s own milk (MOM) or pasteurized donor human milk (PDHM) supplemented with bovine derived human milk fortifier (HMF) were enrolled in the study within 24 hours of life.

Exclusion criteria

Exclusion criteria: Preterm infants who were not compliant with HMF, infants with severe intraventricular hemorrhage (IVH), post hemorrhagic ventricular dilatation (PHVD), meningitis, and poor neurological outcomes at discharge were excluded. We also excluded surgical infants and those with congenital anomalies.

Design outcomes

Primary

MeasureTime frame
gain in weight per dayTimepoint: 28 days

Secondary

MeasureTime frame
anaemia of prematurity (AOP),Timepoint: 28 days;bronchopulmonary dysplasia (BPD)Timepoint: 28 days;late onset sepsisTimepoint: 28 days;mortalityTimepoint: 28 days;osteopenia of prematurity (OOP)Timepoint: 28 days;retinopathy of prematurity (ROP)Timepoint: 28 days;feed intoleranceTimepoint: 28 days;gain in head circumferenceTimepoint: 28 days;gain in lengthTimepoint: 28 days;incidence of NEC as per Bell’s stage =IITimepoint: 28 days

Countries

India

Contacts

Public ContactAnitha Haribalakrishna

Seth GS Medical College and KEM Hospital

ani.gem81@gmail.com09769660870

Outcome results

None listed

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