NCT06026163

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

Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Ministry of Health, Saudi Arabia · Other Government
• Sex: All
• Age: 1 Day – 3 Days
• Healthy volunteers: Not accepted

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.

Detailed description

late preterm infants will be randomized in a blinded manner to receive either caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) in Caffeine treatment group, or equivalent volume of saline in the placebo group. Caffeine will be continued until infants get off all forms of respiratory support. Preparation of caffeine and placebo will be performed by a designated pharmacist who is not part of the study. Parents and investigators will be remained blinded to the administered medications throughout the study period.

Conditions

• Prematurity
• Respiratory Disease
• Ventilator Lung; Newborn

Interventions

Type	Name	Description
DRUG	Caffeine citrate	Caffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base)
OTHER	Placebo	Equivalent volume of saline

Timeline

• Start date: 2023-10-12
• Primary completion: 2027-10-30
• Completion: 2028-01-01
• First posted: 2023-09-06
• Last updated: 2025-06-27

Locations

2 sites across 1 country: Saudi Arabia