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Fast versus slow increase in oral feeds in neonates with umbilical artery abnormalities

Comparison of time to full feed with slow versus rapid advancement of enteral feeding in neonates (28-34+6 weeks of gestation) with antenatal absent end diastolic flow in umbilical artery: A Randomized Control Trial - nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060952
Enrollment
70
Registered
2023-12-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: P052- Newborn affected by fetal (intrauterine) malnutrition not light or small for gestational age Health Condition 2: P059- Newborn affected by slow intrauterine growth, unspecified

Interventions

Intervention1: Rapid feeding Advancement (Total duration: 28 days of life): feeding will be initiated at 6 hours of life (as per unit policy) with 30 ml/kg/day of expressed breast milk (EBM) or pasteu

Sponsors

Lady Hardinge Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonate with gestational age of 28-34+6 weeks with antenatal absent end diastolic flow in umbilical artery on antenatal USG Doppler.

Exclusion criteria

Exclusion criteria: 1. Antenatally diagnosed gastrointestinal (GI) malformation. 2. Presence of major congenital anomalies at birth 3. Baby born with reversal of end diastolic flow in umbilical artery 4. Need of vasopressor support at the time of randomization 5. APGAR score

Design outcomes

Primary

MeasureTime frame
Time taken to reach full enteral feeding (in completed days)Timepoint: Daily till discharge or death—

Secondary

MeasureTime frame
Bronchopulmonary dysplasiaTimepoint: daily till discharge or death;Clinically suspected/Probable/ culture proven late-onset sepsisTimepoint: daily till discharge or death;Feed intoleranceTimepoint: daily till discharge or death;Length of hospital stayTimepoint: daily till discharge or death;Metabolic bone diseaseTimepoint: daily till discharge or death;Necrotizing enterocolitis (NEC) stage IIb & aboveTimepoint: daily till discharge or death;Retinopathy of prematurityTimepoint: daily till discharge or death—

Countries

India

Contacts

Public ContactDr Rajesh kumar

Lady Hardinge Medical college, New Delhi

drsnangia@gmail.com9810838181

Outcome results

None listed

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