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Effect of early prophylactic vs therapeutic caffeine on duration of respiratory support in neonates less than 32 weeks

Efficacy of Early Prophylactic Caffeine Vs Therapeutic Caffeine in Neonates 32 weeks Gestation A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098980
Enrollment
80
Registered
2025-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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 Prophylactic caffeine: Group A: Early Prophylactic caffeine (within 2 hours of birth). Infants randomized to the prophylactic caffeine arm will receive intravenous or oral caffein

Sponsors

Dr. Neelam Kler
Lead Sponsor
Dr Parth Mehta
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All intramural preterm neonates less than 32 weeks gestation on respiratory support at birth.

Exclusion criteria

Exclusion criteria: 1. Gestational age less than 24 weeks. 2. Major congenital anomalies or known genetic/syndromic disorders. 3. Antenatally diagnosed congenital diaphragmatic hernia or severe pulmonary hypo- plasia. 4. Requiring chest compressions and/or medications at birth (adrenaline or volume bolus for resuscitation). 5. Failure to obtain consent.

Design outcomes

Primary

MeasureTime frame
Time to discontinuation of respiratory support.Timepoint: Till Discharge—

Secondary

MeasureTime frame
Time to discontinuation of initial invasive ventilationTimepoint: Till Discharge;Echocardiographic parameters (left ventricular output, right ventricular output, superior vena cava flow, superior mesenteric artery doppler and anterior cerebral artery doppler)Timepoint: 0, 4 hrs and 24-36 hours;Cumulative duration of respiratory support during the hospital stayTimepoint: Till Discharge;Bronchopulmonary dysplasia (BPD) Timepoint: 36 weeks POG;Hemodynamically significant patent ductus arteriosusTimepoint: Day of life 7;Necrotizing enterocolitis (NEC) stageTimepoint: Till Discharge;Growth velocityTimepoint: At discharge;Retinopathy of prematurity (ROP)Timepoint: Till Discharge;Severe intraventricular haemorrhage (IVH) on cranial ultrasonographyTimepoint: Till discharge ;Periventricular leukomalacia (PVL) grade 3 or grade 4 on cranial ultrasonographyTimepoint: Till discharge;Neonatal sepsisTimepoint: Till Discharge;Use of post-natal steroidsTimepoint: Till Discharge;Duration of hospital stayTimepoint: Till Discharge;All-cause mortalityTimepoint: Till Discharge—

Countries

India

Contacts

Public ContactDr Parth Mehta

Sir Ganga Ram Hospital

parthmehtaucms@gmail.com9582291257

Outcome results

None listed

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