A clinical trial to study fortification of human milk when itâ??s done early or delayed in preterm very low birth weight neonates

Impact of early Vs delayed fortification of human milk on growth of preterm very low birth weight neonates-An open label, parallel,randomised control,superiority trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/04/024495

Enrollment

Registered

2020-04-07

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: P84- Other problems with newborn

Interventions

Intervention1: Early fortification: Fortification of human milk is done when the feed volume is 20ml/kg/day Control Intervention1: Delayed fortification: Fortification of human milk is done when the

Eligibility

Inclusion criteria

Inclusion criteria: 1.Neonates with birth weight less than 1500 grams 2.neonates with gestational age less than 37 weeks and 3.neonates receiving 80% of their total feed volume as human milk at the time of recruitment

Exclusion criteria

Exclusion criteria: 1.neonates with major congenital anomalies or suspected chromosomal anomalies 2.neonates with Gastrointestinal conditions requiring surgery

Design outcomes

Primary

Measure	Time frame
Growth of neonates when they reach corrected gestational age of 40 weeksTimepoint: Growth of neonates till they reach corrected gestational age of 40 weeks	—

Secondary

Measure	Time frame
Morbidities of preterm very low birth weight infantsTimepoint: Growth of neonates till they reach corrected gestational age of 40 weeks	—

Countries

India

Contacts

Public ContactDr S Ramesh

PSG Institute of Medical science and Research , Coimbatore

drsramesh95@yahoo.co.in9962823975

Outcome results

None listed

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