A clinical trial to study the effects of adjusted fortification versus standard fortification of human milk in very low birth weight neonates.

Adjusted versus Standard Fortification of human milk in Very Low Birth Weight Neonates â?? A Pilot Randomised Trial.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012462

Enrollment

Registered

2018-03-12

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: null- nutrition

Interventions

Intervention1: adjusted fortification: Human milk fortification will be adjusted based on serum blood urea nitrogen levels in very low birth weight infants. Neonates will be randomised when they reach

Eligibility

Inclusion criteria

Inclusion criteria: birth weight between 750g-1250g gestation 26 weeks+0 to 32 weeks +6 days hemodynamically stable on enteral feeds volume of >140ml/kg/day

Exclusion criteria

Exclusion criteria: parents refused to consent earlier episodes of feed intolerance or NEC IIa or more formula fed or mixed feeding with human milk and formula feed GI surgical conditions Congenital malformations Ongoing Sepsis

Design outcomes

Primary

Measure	Time frame
Rate of weight gain g/kg/dayTimepoint: Till discharge	—

Secondary

Measure	Time frame
duration of hospitalization, osteopenia of prematurity, episodes of feed intolerance, NECIIb or more, new onset sepsis, ROP,Timepoint: till discharge	—

Countries

India

Contacts

Public Contactjenisha chaudhary

Mehta Hospital

tojenisha@gmail.com9826861727

Outcome results

None listed

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