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Study on different strategies of fortification of breast milk in very low birth weight infants to improve growth

Comparison of short term weight gain in very low birth weight (VLBW) neonates receiving expressed breast milk (EBM) fortified with amino acid based powder formula vs conventional human milk fortifier: A randomized clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068977
Enrollment
120
Registered
2024-06-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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: Amino acid based formula powder (Neocate LCP) as fortifier: 1gm in 25 ml of expressed breast milk. Control Intervention1: Conventional Human Milk Fortifier (Lactodex HMF): 1gm in 25 ml

Sponsors

Fernandez Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates who are born before 32weeks of gestational age and are having the following characteristics : a.Birth weight of less 1000gm b.Birth weight between 1000 to 1250gm and are having abnormal doppler studies antenatally or postnatally.

Exclusion criteria

Exclusion criteria: Neonates with the following conditions will be excluded: a. Major congenital malformation b. Hydrops c. Any gastrointestinal surgery prior to intervention.

Design outcomes

Primary

MeasureTime frame
To compare the weight gain in gm/kg/day between the neonates receiving expressed breast milk fortified with amino acid based powder formula vs conventional human milk fortifier.Timepoint: Everyday from the start of fortification (neonates reaching enteral feed of 120ml/kg/day) till discharge from the hospital.

Secondary

MeasureTime frame
Gain in head circumference(cm/week) between both the groups.Timepoint: From the time of onset of fortification( neonates reaching enteral feed of 120ml/kg/day) till discharge from the hospital;Gain in length ( cm/week) between both the groups .Timepoint: From the time of onset of fortification( neonates reaching enteral feed of 120ml/kg/day) till discharge from the hospital;Incidence of neonatal morbidities such as feed intolerance, necrotising enterocolitis , metabolic bone disease etc between both the groups.Timepoint: From the time of onset of fortification( neonates reaching enteral feed of 120ml/kg/day) till discharge from the hospital.

Countries

India

Contacts

Public ContactDr Tejo Pratap Oleti

Fernandez Hospital

tejopratap@gmail.com9989372490

Outcome results

None listed

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