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Comparing Different Caffeine Amounts to Prevent Breathing Problems in Premature Babies: A Study (HI-CAF Trial)

Higher versus Standard Caffeine dosing in Prevention of Apnoea of Prematurity: A Randomized Controlled Trial (HI-CAF trial) - HI-CAF trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063926
Enrollment
348
Registered
2024-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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: higher dose of caffeine: All eligible neonates will be stratified into 2 groups of less than 30 weeks and 30+1 to 31+6 weeks and will be randomised using web based randomisation into 2

Sponsors

Dr Asha M N
Lead Sponsor
Dr Debasish Nanda
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All neonates less than 30 weeks of gestation and Neonates between 30+1 to 31+6 who develop recurrent apnoea.

Exclusion criteria

Exclusion criteria: Major Congenital anomaly or Chromosomal abnormalities and Parents who do not consent

Design outcomes

Primary

MeasureTime frame
The proportion of apnoea of prematurityTimepoint: Upto 28 days of life

Secondary

MeasureTime frame
The rates of failure of extubation.Timepoint: anytime during hospital stay.;Incidence of PDA, NEC, IVH, PVL, ROP and AKI. Timepoint: anytime during hospital stay. ;Duration of respiratory support.Timepoint: anytime during hospital stay. ;The time to reach full enteral feeding.Timepoint: anytime during hospital stay.;Number of NPO hoursTimepoint: anytime during hospital stay.;The incidence of Hypertension. Timepoint: anytime during hospital stay.;Growth velocities( average weekly weight gain in first month of life and average weight gain during NICU stay) Timepoint: anytime during hospital stay.;The incidence of Seizures. Timepoint: anytime during hospital stay.;Severe adverse events. Timepoint: anytime during hospital stay.;BPD Timepoint: anytime during hospital stay.;Mortality Timepoint: anytime during hospital stay.

Countries

India

Contacts

Public ContactDr Asha M N

IMS and SUM Hospital

debasishnanda@soa.ac.in9861422685

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 9, 2026