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Breastmilk fortification with human milk derived human milk fortifier-RCT

Breastmilk fortification with human milk derived human milk fortifier (HHMF) versus bovine milk derived human milk fortifier (BMHF)in preterm infants in preterm infants less than 30 weeks gestation A randomised control non inferiority trial from western India.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048975
Enrollment
50
Registered
2023-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: P788- Other specified perinatal digestive system disorders

Interventions

Intervention1: Human Milk derived human milk fortifier: Human Milk derived human milk fortifier will be used to fortify human milk Frequency- With each feed Total duration- Until discharge Control In

Sponsors

Department of Neonatology KEM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants born at or before 30 weeks of gestation with birth weight less than 1000 g. and receiving 100 mL kg per day of enteral human milk feeds

Exclusion criteria

Exclusion criteria: Major congenital anomaly

Design outcomes

Primary

MeasureTime frame
Rate of in-hospital weight gain measured as gram per kilogram per day from the day of initiating fortificationTimepoint: day of discharge or 40 weeksâ?? PMA, whichever is earlier.—

Secondary

MeasureTime frame
Time to reach full feeds: a feed volume of 150ml/kg/day Rate of in-hospital length and head circumference growth measured as cm per day from the day of initiating fortification Incidence of feed intolerance Incidence of Necrotizing enterocolitis (NEC) Incidence of late onset sepsis Incidence of Extrauterine growth restriction (EUGR) Mortality Timepoint: to the day of discharge or 40 weeksâ?? PMA, whichever is earlier—

Countries

India

Contacts

Public ContactDrAnitha haribalakrishna

Department of Neonatology Seth GSMC KEM hospital

ani.gem81@gmail.com9769660870

Outcome results

None listed

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