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Effect of Human Milk Fortification Beyond Hospital Discharge on the Growth of Premature Infants

Effect of of Sustained Multi-nutrient Milk Fortification beyond Hospital Discharge on the growth of Very Preterm Infants - a Randomized Control Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044831
Enrollment
50
Registered
2022-08-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: P051- Newborn small for gestational age Health Condition 2: P071- Other low birth weight newborn Health Condition 3: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Sustained milk fortification beyond hospital discharge: Sustained milk fortification with multi-nutrient fortifier following hospital discharge till 40 weeks P.M.A. Control Intervention

Sponsors

Shrutiprajna Kar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All preterm babies between 26 to 32 weeks gestation or birthweight less than 1500 grams with multi-nutrient milk fortification started during hospital stay

Exclusion criteria

Exclusion criteria: 1. Neonates with major gastro-intestinal congenital malformations 2. Syndromic neonates assessed antenatally or postnatally

Design outcomes

Primary

MeasureTime frame
To compare the rate of weight gain (grams/kg/day) at 40 weeks P.M.A. in preterm (26-32 weeks gestation) or VLBW neonates (1500 grams) being continued on fortified breast milk beyond discharge with those who received unfortified breast milkTimepoint: Baseline and 40 weeks postmenstrual age

Secondary

MeasureTime frame
To calculate cZ scores (change in Z score of weight, length & height from birth) at term equivalent according to modified Fentons growth charts Timepoint: Term equivalent age;To compare the rate of increase in head circumference (cm/week) from birth till term equivalent age Timepoint: Term equivalent age;To compare the rate of increase in length (cm/week) from birth till term equivalent age Timepoint: Term equivalent age;To estimate the percentage of Extrauterine growth restriction at 40 weeks P.M.A. Timepoint: Term equivalent age

Countries

India

Contacts

Public ContactDr Pankaj Kumar Mohanty

All India Institute of Medical Sciences, Bhubaneswar

neonat_pankaj@aiimsbhubaneswar.edu.in9078823780

Outcome results

None listed

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