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Early full feeding in stable neonates <1500g birthweight- a clinical trial

Early total enteral feeding versus gradual feed increment practice in stable very low birth weight infants- A randomized controlled non-inferiority trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069212
Enrollment
110
Registered
2024-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: P789- Perinatal digestive system disorder, unspecified

Interventions

Intervention1: Early total Enteral Feeding: Within 24 hours of life,, full total enteral feeds would be initiated with 80ml /kg/day of human milk and will be advancement at 20ml /kg/day Control Interv

Sponsors

Seth GS Medical College and KEM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All AGA and SGA babies without doppler changes

Exclusion criteria

Exclusion criteria: Infants with serious congenital anomalies that are incompatible with life Infants requiring major gastrointestinal surgeries in the first week of life. Outborn infants admitted to the unit after initiation of feeds. Infants with significant antenatal Doppler abnormalities. Infants requiring resuscitation in the form of positive pressure ventilation/ intubation or medication. Infants on invasive mechanical ventilation Infants on non invasive mechanical ventilation with fio2 requirement more than 30% or CPAP more than Infants on inotropic support

Design outcomes

Primary

MeasureTime frame
To compare the rate of extrauterine growth restriction among stable VLBW infants at 28-32 weeks and/or 1000-1250g on ETEF.Timepoint: To compare the rate of extrauterine growth restriction among stable VLBW infants at 28-32 weeks and/or 1000-1250g on ETEF.

Secondary

MeasureTime frame
Cumulative weight gain Cumulative length gain Cumulative gain in head circumference Hospital stay duration All cause mortality time to reach full feeds 150ml/kg/da Time to regain birth weight Weekly enteral feed intake NEC BPD HSPDA ANemia Hypoglycemia Sepsis ROP Metabolic bone disease Timepoint: At Term gestation or discharge

Countries

India

Contacts

Public ContactDr Anitha Haribalakrishna

Seth GSMC and KEM Hospital

ani.gem81@gmail.com9769660870

Outcome results

None listed

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