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Body fat and fat free mass determination in babies born between 28-34 week with birth weight less than 1500 g given only breast milk feeding compared to those given breast milk supplemented with nutrients feeding: A comparison trial

Body composition (fat mass and fat free mass) in preterm (28-34 week) very low birth weight (less than 1500 g) infants fed unfortified breast milk compared to fortified breast milk: A randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019513
Enrollment
140
Registered
2019-06-04
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: E44- Protein-calorie malnutrition of moderate and mild degree

Interventions

Intervention1: Unfortified breast milk: Unfortified breast milk given at higher volume (approx 200 mL/kg/day in 12 divided feeds) till 40 weeks corrected age/full direct breast feeding Control Interve

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Satisfying all 3 below conditions 1. Preterm infants (28 0/7 to 34 6/7 weeks AND 2. Accepting full oral feeds (120-150 mL/kg) AND 3. At least 75% of the total daily milk intake at that time point (evaluated as proportion of feeds in last 24 hours) should be motherâ??s own milk.

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies including acyanotic heart disease, gastrointestinal anomalies 2. Hydrops 3. Consent denied

Design outcomes

Primary

MeasureTime frame
1. To evaluate the body composition (fat mass (FM), fat free mass (FFM), FM% and FM and FFM index) in preterm infants (28 0/7 to 34 6/7 weeks AND 1500 g birth weight) receiving â??motherâ??s own milk without HMF fortificationâ?? with feeding volume of up to 220 mL/kg compared to â??human breast milk with HMF fortification in 180 mL/kgâ?? at 40 ± 2 weeks PMA.Timepoint: At 40 ± 2 weeks postmenstrual age—

Secondary

MeasureTime frame
1. To evaluate weight gain, head circumference growth and length growth rate of these infants at 40 ± 2 weeks PMA. 2. To evaluate the morbidities in the two groups and the safety of high volume enteral feeding in preterm infants (28 0/7 to 34 6/7 weeks AND 1500 g birth weight) during hospital stay. 3. To evaluate the body composition (FM, FFM, FM% and FM index) of these infants at 3 ± 1 month of corrected age.Timepoint: At 40 ± 2 weeks postmenstrual age. At 3 ± 1 month of corrected age.—

Countries

India

Contacts

Public ContactDr Anu Sachdeva

All India Institute of Medical Sciences

dranuthukral@gmail.com9871788561

Outcome results

None listed

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