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Feeding and fasting study of babies with birth asphyxia

Enteral Feeding versus Fasting during Therapeutic Hypothermia in neonates with moderate and severe Hypoxic Ischemic Encephalopathy- A Randomised Controlled trial. - FEEDFAST TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030787
Enrollment
20
Registered
2021-01-27
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: G969- Disorder of central nervous system, unspecified

Interventions

Intervention1: Interventional Group: Minimal Enteral Nutrition to be started within 24 hours of life. Orogastric tube feeds of EBM/PDHM only (strictly no formula feeds) to be initiated @ 20 ml/kg/day

Sponsors

Goa Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants born at 36 weeks or later and more than 1.8kgs, who received therapeutic hypothermia for Hypoxic Ischaemic Encephalopathy (HIE) for at least 72 hours.

Exclusion criteria

Exclusion criteria: 1.Presence of major congenital anomalies. 2.Hypotension requiring 2 or more ionotropes. 3.Severe acidosis on arterial blood gas (ph 4.Antenatal diagnosis of Gastrointestinal surgical obstruction or clinical evidence (abdominal distension or bilious aspirate) at birth.

Design outcomes

Primary

MeasureTime frame
1.Necrotising enterocolitis during NICU stay. 2.Neurodevelopmental outcomes at 18-24 months. Timepoint: 1.Necrotising enterocolitis during NICU stay. 2.Neurodevelopmental outcomes at 18-24 months.—

Secondary

MeasureTime frame
1.Mortality in the neonatal period (birth to 28 days). 2.Episodes of feed intolerance. 3.Time to reach full enteral feeds. 4.Duration of parenteral nutrition/Intravenous fluids. 5.Length of stay in the NICU. 6.Number of days of central lines with incidence of CLABSI. 7.Growth (weight and head circumference during NICU stay and at discharge). 8.Magnetic resonance imaging findings. Timepoint: 1. Mortality in the neonatal period (birth to 28 days). 2. Episodes of feed intolerance. 3. Time to reach full enteral feeds. 4. Duration of parenteral nutrition/Intravenous fluids. 5. Length of stay in the NICU. 6. Number of days of central lines with incidence of CLABSI. 7. Growth (weight and head circumference during NICU stay and at discharge). 8. Magnetic resonance imaging findings.—

Countries

India

Contacts

Public ContactBonny Baracho

Goa Medical College.

kantakum@yahoo.com9422454850

Outcome results

None listed

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