Clinical Trial

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

Study acronym: CAT/LPT
Recruiting Phase 2/3
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-09-03; most recent amendment 2025-06-24.
Status change: Not Yet Recruiting → Recruiting 2025-01-01
Trial Details
NCT Number NCT06026163
Lead Sponsor Ministry of Health, Saudi Arabia
Conditions Prematurity, Respiratory Disease, Ventilator Lung; Newborn
Enrollment 134 participants
Start Date 2023-10-12
Primary Completion 2027-10-30 (estimated)
Study Completion 2028-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-06-27