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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 gestation

Comparison of the growth in preterm neonates less than 32 weeks of gestation on Human milk derived fortifier versus Bovine milk derived fortifier - A Randomized Controlled Trial - BoMan

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039230
Enrollment
106
Registered
2022-01-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: Human milk derived fortifier: 1 gm of Human milk derived fortifier added in 25 ml of human milk and given with each feed till discharge or 2kg weight Control Intervention1: Bovine milk

Sponsors

Mehta Multispecialty Hospitals India Pvt Ltd chetpet Chenna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates with gestational age <32weeks admitted to NICU

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Increase in growth parameters by measuring weight, length and head circumference at discharge.Timepoint: Discharge or at weight gain of 2 Kg.—

Secondary

MeasureTime frame
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 Timepoint: till discharge;Feed interruptions- withholding feeds for more than 12hours 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 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. Timepoint: till discharge—

Countries

India

Contacts

Public ContactDr Meenakshi Singh Kushwah

Mehta Multispecialty Hospitals India Pvt. Ltd

drlakshmi2008@gmail.com9840211742

Outcome results

None listed

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