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Early versus Routine Caffeine Use in Premature Infants: a study to improve breathing outcomes

Early versus Routine Caffeine Administration in Very Preterm Neonates- a Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096280
Enrollment
80
Registered
2025-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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: Early Caffeine: Administration of Caffeine within one hour after birth Control Intervention1: Routine caffeine: Administration of caffeine within one to three hours after birth

Sponsors

Dr Nishant Banait
Lead Sponsor
Dr Anuja Bedekar
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates born at less than 32 weeks gestational age admitted to NICU at AIIMS Nagpur within 3 hours after birth

Exclusion criteria

Exclusion criteria: 1. Parents and guardians unwilling to provide consent for the study 2. Major Congenital malformations 3. Severe perinatal asphyxia (Apgar score less than 3 at 10 minutes, requiring positive pressure ventilation for more than 10 minutes, requiring chest compressions)

Design outcomes

Primary

MeasureTime frame
Incidence of bronchopulmonary dysplasiaTimepoint: Requirement of supplemental oxygen at 36 completed weeks of gestational age

Secondary

MeasureTime frame
Requirement of invasive ventilationTimepoint: Requirement of invasive ventilation for more Tham initial 12 hours;Total number of days on mechanical ventilationTimepoint: till discharge;Total number of days on oxygen supportTimepoint: till discharge;Total duration of NICU stayTimepoint: till discharge;Postnatal steroid administrationTimepoint: till discharge;Echocardiographic parameters of systemic blood flowTimepoint: During initial 48 hours of life

Countries

India

Contacts

Public ContactDr Anuja Bedekar

All India Institute of Medical Sciences, Nagpur

dranujabedekar@aiimsnagpur.edu.in7387106550

Outcome results

None listed

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