Effect of Early initiation of breast milk fortification

Randomized controlled trial on Effect of early initiation of breast milk fortification on growth in preterm neonates. - nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064394

Enrollment

100

Registered

2024-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: P788- Other specified perinatal digestive system disorders

Interventions

Intervention1: early fortification of breast milk: Intervention group will get fortification of breast milk when the child reach 150ml/kg/day. Fortification will be done till 36 weeks post menstrual a

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates of birth weight less than 1250g admitted in the neonatal unit

Exclusion criteria

Exclusion criteria: 1.Congenital malformation 2.Surgical conditions of abdomen where feeding can’t be initiated 3.Reverse end-diastolic flow (REDF) 4.On full formula feed at the time of enrolment 5.Refusal for donor human milk

Design outcomes

Primary

Measure	Time frame
growth during hospital stay and during discharge or 36weeks PMA which ever is earlierTimepoint: 36weeks PMA or at discharge which ever is earlier	—

Secondary

Measure	Time frame
Feed intolerance osteopenia of prematurityTimepoint: 36weeks PMA	—

Countries

India

Contacts

Public ContactDr Kanya Mukhopadhyay

PGI Chandigarh

kanyapgi@gmail.com01722755266

Outcome results

None listed

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