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
Not Applicable
- Conditions
- Health Condition 1: E44- Protein-calorie malnutrition of moderate and mild degree
- Registration Number
- CTRI/2019/06/019513
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Satisfying all 3 below conditions
1. Preterm infants (28 0/7 to 34 6/7 weeks AND <1500 g birth weight) 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
1. Major congenital anomalies including acyanotic heart disease, gastrointestinal anomalies
2. Hydrops
3. Consent denied
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. To evaluate weight gain, head circumference growth and length growth rate of these infants at 40 ± 2 weeks PMA. <br/ ><br>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. <br/ ><br>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. <br/ ><br> <br/ ><br>At 3 ± 1 month of corrected age.