drugset / Trial / NCT06026163

Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress

NCT06026163

Phase 2/3 Recruiting 134 enrolled Ministry of Health, Saudi Arabia
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20 mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively. The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants. The investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.

Timeline

Start
2023-10-12
Primary completion
2027-10-30
Completion
2028-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Caffeine Small molecule 10 mg/kg

Indications