Evaluation of the Efficacy of Caffeine in Reducing the Duration of Respiratory Support in Preterm Neonates

Efficacy of Oral Caffeine on Duration of Respiratory Support in Preterm Neonates Weighing 1250 to 2000 gram: A Randomized Controlled Trial - CURE-N

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087145

Enrollment

172

Registered

2025-05-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: P229- Respiratory distress of newborn, unspecified

Interventions

Intervention1: Oral Caffeine Citrate: 1)Preparation of the drug: Oral caffeine citrate is commercially available as a colorless, transparent liquid oral solution. Each milliliter (ml) contains 20 mg o

Eligibility

Inclusion criteria

Inclusion criteria: All inborn neonates with a gestation age of between 30 to 36+6 weeks AND Birth weight between 1250 to 2000 gram AND Requiring respiratory support since birth for a duration of more than 6 hours.

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies and chromosomal disorder 2. Hypoxic ischemic encephalopathy stage II or above 3. Neonates kept nil per mouth beyond 24 hours of life 4. Neonates on multiple (>=2) inotropes

Design outcomes

Primary

Measure	Time frame
Total Duration of Respiratory support (Invasive + Non-invasive) in hoursTimepoint: The exact hour of life at which respiratory support is discontinued.	—

Secondary

Measure	Time frame
Total duration of hospital stay in daysTimepoint: At the time of discharge from NICU;Neonatal death by day 7 and 28 (all cause)Timepoint: At completed 7 days and 28 days, respectively;Prevalence of feed intoleranceTimepoint: Till caffeine is ongoing	—

Countries

India

Contacts

Public ContactDr Bhabesh Kant Chowdhry

All India Institute of Medical Sciences, Patna

drbhabeshkc@aiimspatna.org917871592369

Outcome results

None listed

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