NCT06905496

Apnea of Prematurity Results in Respiratory Distress and Cyanosis. Caffeine Citrate Can Treat It.

Comparison of Outcomes of High Dose Verses Low Dose Caffeine Citrate in the Treatment of Apnea of Prematurity

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Nishtar Medical University · Academic / Other
• Sex: All
• Age: 1 Day – 10 Days
• Healthy volunteers: Not accepted

Summary

High-dose caffeine citrate is more effective than low-dose caffeine citrate in the treatment of apnea of prematurity (AOP). The high-dose group showed fewer apnea episodes, higher extubation success rate, lower extubation failure rate and shorter duration of oxygen therapy

Detailed description

Apnea of prematurity (AOP) is a common condition in preterm infants due to immature respiratory control, affecting up to 80% of those under 1000 grams. It can lead to serious complications, including respiratory distress, pulmonary hemorrhage, and developmental delays. Caffeine citrate, a methylxanthine, is widely used for AOP treatment due to its longer half-life and better absorption compared to theophylline. However, the optimal dosage remains uncertain, with varying practices globally.

Conditions

• Apnea of Prematurity

Interventions

Type	Name	Description
DRUG	High-Dose	Caffeine
DRUG	Low Dose	Caffeine citrate is a combination of caffeine and citric acid, commonly used as a central nervous system stimulant. It is primarily used to treat apnea of prematurity in neonates.

Timeline

• Start date: 2024-06-03
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2025-04-01
• Last updated: 2025-04-01

Locations

1 site across 1 country: Pakistan