Fortification of expressed breast milk with preterm formula Vs commercial fortifiers in preterm very low birth weight infants
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Preterm (28 - 34 weeks POG) Very low birth weight neonatesHealth Condition 2: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2017/11/010593
- Lead Sponsor
- All India Institute of Medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 123
Inclusion Criteria
1.Preterm neonates born between 28 and 34 weeks of gestation
2.Birth weight less than 1500 g
3.Accepting oral feeds of at least 100ml/kg/day
4.Amount of EBM, as a proportion of total daily milk intake, 75% or greater at enrollment.
Exclusion Criteria
Major congenital anomalies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of weight gain from the time of fortification till hospital dischargeTimepoint: Day 7,14,21,28 or till discharge, whichever is earlier
- Secondary Outcome Measures
Name Time Method Incidence of morbidities like late metabolic acidosis, necrotizing enterocolitis, osteopenia of prematurity, anemia requiring blood transfusionsTimepoint: Day 1,2,3 till hospital discharge and at 40 wks PMA;Proportion of babies found to be growth restricted at term gestationTimepoint: At 40 wks PMA;Proportion of infants needing crossing over to other armTimepoint: Day 1,2,3 till hospital discharge;Weekly rate of gain in length and head circumferenceTimepoint: Day 7,14,21,28 or at discharge, whichever is earlier