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Early additional feeds along with breastmilk in newborn infants at risk of low sugar levels

Early add on enteral feeding VS standard feeding practice in late preterm and term infants at risk of hypoglycemia - A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073305
Enrollment
170
Registered
2024-09-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: Early add-on feeding group: Add-on feeds will be given as preterm formula feed and term formula feed along with direct breast feeds during the first three days of life. Feed volume will

Sponsors

Seth GS Medical College and KEM hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Gestational age more than 35 weeks with birth weight less than 2.5 kg Small for gestational age as per modified Fentonâ??s growth chart in preterm and WHO growth chart in term infants. Large for gestational age infants Infants with birth weight at term >3.5 Kg Infant of diabetic mother

Exclusion criteria

Exclusion criteria: Antenatally diagnosed AEDF, major life threatening congenital anomalies, neonates requiring NICU admission shortly after birth, severe birth asphyxia, infants requiring oxygen support or respiratory support and surgical conditions, infants with feeding issues, infants with feeding issues like cleft palate, retrognathia, Pierre Robin sequence or on tubes feeds, infants with symptomatic hypoglycemia or asymptomatic with one hour prefeed sugar less than 35 mg/dL.

Design outcomes

Primary

MeasureTime frame
incidence of hypoglycemiaTimepoint: 7 days

Secondary

MeasureTime frame
Requirement of intravenous glucoseTimepoint: 7 days;Late onset sepsisTimepoint: 28 days;Duration of hospital stayTimepoint: 28 days;Neonatal hyperbilirubinemia requiring phototherapyTimepoint: 7 days;Time to regain birth weightTimepoint: 14 days;weekly gain of weight, length and head circumferenceTimepoint: 28 days;incidence of feed intolerenceTimepoint: 28 days;incidence of exclusive breastfeeding till six months of ageTimepoint: 6 months;Neurodevelopmental outcome at 1 year of ageTimepoint: 1 year

Countries

India

Contacts

Public ContactAnitha Haribalakrishna

Seth G.S. Medical College & KEM Hospital

ani.gem81@gmail.com9769660870

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026