A study comparing the effects of adding extra nutrients to breast milk early versus later on the growth of premature babies weighing less than 1500 grams.

Effect of Early Fortification Versus Delayed Fortification of Human Milk on Anthropometric Parameters in Very Low birth Weight Infants: A Randomized Controlled Trial - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/081432

Enrollment

Registered

2025-02-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: P969- Condition originating in the perinatal period, unspecified Health Condition 2: P84- Other problems with newborn

Interventions

Intervention1: Fortification of human milk: This study aimed to compare early fortification (feed volume 80ml/kg/day) versus delayed fortification (120 ml/kg/day). Control Intervention1: FORTIFICA

Eligibility

Inclusion criteria

Inclusion criteria: All inborn newborn admitted in NICU with Birth weight less than 1500 grams Gestation more than or equal to 26 weeks

Exclusion criteria

Exclusion criteria: Major congenital anomalies

Design outcomes

Primary

Measure	Time frame
Time to regain birth weight (in days) and subsequent rate of weight gain (gram/kg/day) at 4 weeks of postnatal age or discharge whichever is earlierTimepoint: Time to regain birth weight (in days) and subsequent rate of weight gain (gram/kg/day) at 4 weeks of postnatal age or discharge whichever is earlier	—

Secondary

Measure	Time frame
increase in head circumference (cm/week) and length (cm/week) till discharge.Timepoint: till discharge;Correlation between total protein intake and time to regain birth weight in days , weight gain velocity , head circumference cm/ week, length cm /week.Timepoint: till discharge;Incidence of NEC stage 2 or more as per modified Bell s stage.Timepoint: till discharge;Feed intolerance incidenceTimepoint: till discharge;All cause mortality(In hospital)Timepoint: till discharge;Incidence of extrauterine growth restriction at discharge (number of infants with weight < 10th percentile for the index population)Timepoint: till discharge;Incidence of ROP requiring treatmentTimepoint: Till discharge;BPD incidenceTimepoint: till discharge	—

Measure

Time frame

increase in head circumference (cm/week) and length (cm/week) till discharge.Timepoint: till discharge;Correlation between total protein intake and time to regain birth weight in days , weight gain velocity , head circumference cm/ week, length cm /week.Timepoint: till discharge;Incidence of NEC stage 2 or more as per modified Bell s stage.Timepoint: till discharge;Feed intolerance incidenceTimepoint: till discharge;All cause mortality(In hospital)Timepoint: till discharge;Incidence of extrauterine growth restriction at discharge (number of infants with weight < 10th percentile for the index population)Timepoint: till discharge;Incidence of ROP requiring treatmentTimepoint: Till discharge;BPD incidenceTimepoint: till discharge

—

Countries

India

Contacts

Public ContactAnilkumar J S

All India Institute of Medical sciences, Jodhpur

drsusil85@gmail.com9013355932

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026