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To compare the efficacy of fortifiers derived from human milk versus bovine milk derived fortifiers for weight gain in preterm infants

COMPARATIVE EFFICACY OF HUMAN MILK-DERIVED FORTIFIERS WITH BOVINE MILK DERIVED FORTIFIERS FOR WEIGHT GAIN IN PRETERM INFANTS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042037
Enrollment
148
Registered
2022-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Health Condition 1: P00-P96- Certain conditions originating in the perinatal period Health Condition 2: P00-P96- Certain conditions originating in the perinatal period Health Condition 3: P071- Other low birth weight newborn

Interventions

Intervention1: HUMAN MILK DERIVED FORTIFIERS: Intervention group will recieve human milk based fortifier Neo Lact MMF Sachet ( 1 gm each) by NeoLacta Lifesciences Pvt Ltd,1 gram sachet in 25 ml of mil

Sponsors

DrShreeya Rajput
Lead Sponsor
DrAnumodanGupta
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Neonates with birth weight of 1000-1500 grams and or Gestational age 28 -34 weeks Fortification will be done when baby feed volume will reach 100 ml /kd /day of feed.

Exclusion criteria

Exclusion criteria: 1.Congenital and Gastrointestinal anomalies 2.Necrotizing enterocolitis 3.Neonates with invasive ventilator support 4.Antenatal USG documented REDF and AEDF 5.Requirement of vasopressor support to maintain blood pressure at the time of initiation of feeds. 6.Infants not fit for enteral nutrition ( Abdominsl distension ,Vomiting ).

Design outcomes

Primary

MeasureTime frame
Rate of increase of Weight (g/kg/d)Timepoint: Rate of increase of Weight (g/kg/d) at 4 weeks

Secondary

MeasureTime frame
1.Length (cm/week) 2.Head circumference (cm/week) 3.Feeding intolerance days. 4.Incidence of Necrotizing enterocolitis. 5.Length of hospital stayTimepoint: Based on total duration of weight gain that is measured over 4 weeks.

Countries

India

Contacts

Public ContactDr Shreeya Rajput

Government Medical College

bhatti.anuj@gmail.com9419221115

Outcome results

None listed

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