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A clinical trial to study the effect of two drugs,caffeine & aminophylline in preterm babies with cessation of breathing due to prematurity

Comparing the efficacy ,safety and cost effectiveness of Caffeine Versus Aminophylline for Apnea of Prematurity in Indian Neonates - Prospective RCT - CAAP Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/08/002904
Enrollment
225
Registered
2012-08-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Preterm neonates

Interventions

Intervention1: Caffeine citrate: Loading dose 20mg/kg/day Maintainence dose 5mg/kg/day Will be given as IV till the neonate tolerates orally, then changed over to oral preparation.Drug will be contin

Sponsors

Indian Council of Medical Research ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: For study purpose, neonates will be divided into two groups i) ii) 29 to 34 completed weeks of gestation

Exclusion criteria

Exclusion criteria: 1. Dysmorphic features or congenital abnormalities likely to affect life or neurologic development 2. Parents declined consent 3. Neonates were unlikely to be available for long-term follow-up 4. Previously treated with a methylxanthine

Design outcomes

Primary

MeasureTime frame
1.The main outcome variable will be the comparison of occurrence and frequency of apnoeic episodes in the two groups and failure of treatment defined as [13] - 50% reduction in apneic episodes, - use of IPPV 2. Cost-effectiveness analysis The secondary outcome measures will include duration of hospital stay, short term growth, adverse effects in two groups, gastric tolerance, need for invasive ventilation, effect on cardiac output and cerebral perfusion.Timepoint: Till discharge

Secondary

MeasureTime frame
The secondary outcome measures will include duration of hospital stay, short term growth, adverse effects in two groups, gastric tolerance, need for invasive ventilation, effect on cardiac output and cerebral perfusion.Timepoint: Till discharge

Countries

India

Contacts

Public ContactDr Leslie Lewis

Kasturba Medical college hospital Manipal,Karnataka

mdnajih@gmail.com7760064710

Outcome results

None listed

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