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Early Fortification on Growth Parameters in Neonates less than 32weeks of Gestation : A Randomized Trial.

NEOFORT Effect of Early Fortification on Growth Parameters at Discharge in Neonates less than 32weeks of Gestation A Randomized Controlled Trial. - Effect of Early Fortification on Growth Parameters at Discharge in Neonates less than 32weeks of Gestation A Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/086024
Enrollment
108
Registered
2025-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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: Early Fortification: Early fortification (Intervention Group) Initiation of enteral feedings, enteral volume advancement, and weaning off parental nutrition will follow the standardiz

Sponsors

Sri Ramachandre Institute of Higher Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All intramural, and extramural neonates retrieved within 12 hours of life, with gestational age at birth less than 32 weeks and or birth weight less than 1500 grams on mothers own milk or PDHM.

Exclusion criteria

Exclusion criteria: Neonates with major congenital malformations or surgical problems or on formula feeds.

Design outcomes

Primary

MeasureTime frame
To evaluate weight gain velocity in VLBW who receive early HM fortification compared to standard care protocolsTimepoint: at the time of discharge

Secondary

MeasureTime frame
1. To evaluate mean duration to regain birthweight. 2. Other growth parameters (head circumference and linear growth velocity) 3. Incidence of feed intolerance. 4. Incidence of Necrotizing Enterocolitis (NEC) stage 2,3. 5. Time to reach full feeds 150ml/kg/day. 6. Incidence of EUGR. Timepoint: at the time of discharge

Countries

India

Contacts

Public ContactRajarajan Paulpandian

Sri Ramachandra Institute of Higher Education and Research

drumarajakumar@gmail.com9941853855

Outcome results

None listed

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