FindTrial
Sign In

Large amount versus standard amount feeding in preterm infants

Large Volume Feed versus standard volume feed in Early Preterm infants of 28-32 weeks gestation: a randomized non-inferiority controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/058155
Enrollment
84
Registered
2023-09-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: large volume total enteral feeds: expressed breastmilk or pasteurised donor human milk will be given to a total volume of 180-200 ml/Kg/day upon reaching full enteral feeding Control In

Sponsors

Anitha Haribalakrishna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: any preterm infants of 28 to 32 weeks gestation

Exclusion criteria

Exclusion criteria: Preterm with congenital anomalies Severe birth asphyxia Grade II or higher Intraventricular hemorrhage Surgical neonates Absent or reverse end diastolic flow in antenatal Doppler

Design outcomes

Primary

MeasureTime frame
The primary outcome is survival without moderate or severe neurodevelopmental disability at 12 months of age corrected for gestational age at birth.Timepoint: 1year—

Secondary

MeasureTime frame
Time to reach full enteral feeds Duration of intravenous fluids Duration of hospital stay Incidence of NEC: as per Bell’s stage =2 Incidence of feed intolerance: Incidence of late onset sepsis Mortality Growth Timepoint: 28 days—

Countries

India

Contacts

Public ContactAnitha Haribalakrishna

Seth GSMC and KEM Hospital

ani.gem81@gmail.com9769660870

Outcome results

None listed

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