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Effect of early total versus gradual introduction of enteral feeds on very preterm neonatal outcomes

Effect of early total versus gradual enteral feeding on short term outcomes in neonates less than 32 weeks of gestation - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060551
Enrollment
140
Registered
2023-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: TEST GROUP: Early full enteral feeds, i.e feeds commenced from day 1 of life Control Intervention1: CONTROL GROUP: Enteral feeds will start with 20mL/kg on day 1, then advanced by 20 mL

Sponsors

Dr N D Vaswani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Very preterm neonates with gestational age 28 to 31+6 (after taking informed parental consent) weeks fulfilling the following criterion 1.Hemo dynamically stable neonates 2.No abdominal distention

Exclusion criteria

Exclusion criteria: 1. Gestational age less than 28 weeks 2. Severe birth asphyxia 3. Major gastro intestinal congenital anomalies 4. Absence /reversed end diastolic flow in the umbilical artery on antenatal USG 5. Respiratory support beyond nasal prongs, CPAP, NIMV 6. Shock

Design outcomes

Primary

MeasureTime frame
The time to reach full feeds in early total enterally fed as compared to gradually fed newbornsTimepoint: Any time during the study period

Secondary

MeasureTime frame
To determine the incidence of sepsis, Necrotising enterocolitis(NEC), episodes of feed intolerance, duration of hospital stay, anthropometric indices, till discharge in the two feeding groupsTimepoint: Any time during the study period

Countries

India

Contacts

Public ContactDr Ritika Singh

Pt. B D Sharma Post Graduate Institute of Medical Sciences, Rohtak

ndvaswani@hotmail.com9466676863

Outcome results

None listed

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