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A clinical trial to compare the effect of two feeding schedules: 2 hourly vs 3 hourly on time to reach full oral feeds in babies less than 1500 gm

Randomized controlled trial to evaluate 2 and 3 hourly feeding regime to reach full enteral feeds in very low birth weight neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035735
Enrollment
62
Registered
2021-08-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: P071- Other low birth weight newborn

Interventions

Intervention1: 2 hourly feeding: Feed will be given 2 hourly Control Intervention1: 3 hourly feeding: Feed will be given 3 hourly

Sponsors

Shubham Samaiya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All newborns less than 1500 gm birth weight are eligible for the study

Exclusion criteria

Exclusion criteria: 1) Severe birth asphyxia(APGAR less than 3 at 5 minutes) 2) congenital heart disease 3) gastrointestinal anomalies 4) chromosomal abnormalities 5) major congenital anomalies

Design outcomes

Primary

MeasureTime frame
Time to reach full enteral feedsTimepoint: Till Hospital stay

Secondary

MeasureTime frame
ApneaTimepoint: Till Hospital stay;Cultural positive sepsisTimepoint: Till Hospital stay;Feed intoleranceTimepoint: Till Hospital stay;hyperbilirubinemiaTimepoint: Till Hospital stay;HypoglycemiaTimepoint: Till Hospital stay;Time to regain birth weightTimepoint: Till Hospital stay

Countries

India

Contacts

Public ContactNarendra Kumar Jha

Max Superspeciality Hospital, Vaishali

jhanarendra34@gmail.com9911316816

Outcome results

None listed

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