Randomized trial of Human milk derived fortifiers versus Bovine milk derived fortifiers in comparing the growth parameters in preterm infants less than 32 weeks of gestatio
Not Applicable
- Conditions
- Health Condition 1: 4- Measurement and Monitoring
- Registration Number
- CTRI/2022/01/039230
- Lead Sponsor
- Mehta Multispecialty Hospitals India Pvt Ltd chetpet Chenna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Neonates with gestational age <32weeks admitted to NIC
Exclusion Criteria
1.Parents not willing to give consent for fortification of human milk
2.Neonates more than 1800 grams
3.Neonates with major congenital or chromosomal malformations
4.Infant receives formula or a nutrient fortifier prior to randomization
5.Enrolment in another research study affecting nutritional management during the feeding intervention
6.Mothers who did not consent for other breast milk (OBM) in the absence of her own breast milk.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increase in growth parameters by measuring weight, length and head circumference at discharge.Timepoint: Discharge or at weight gain of 2 Kg.
- Secondary Outcome Measures
Name Time Method Biochemical parameters like serum calcium, phosphorus, alkaline phosphatase, vitamin D3, blood urea nitrogen (BUN), hemoglobin, serum sodiumTimepoint: till discharge;Duration of hospital stayTimepoint: till discharge;Episodes of feed intolerance <br/ ><br>Timepoint: till discharge;Feed interruptions- withholding feeds for more than 12hours <br/ ><br>Timepoint: till discharge;Incidences of â?? Necrotizing enterocolitis (NEC),Late onset sepsis (LOS),Retinopathy of prematurity (ROP), Bronchopulmonary dysplasia (BPD)Timepoint: till discharge;Neurodevelopmental outcome <br/ ><br>Timepoint: till 12 months of chronological age.;Number of days to achieve full feeds (at least 150 ml/kg/day)Timepoint: till discharge;The time taken to regain the birth weight. <br/ ><br>Timepoint: till discharge