RecruitingPhase 2Phase 3NCT06026163

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

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


Sponsor

Ministry of Health, Saudi Arabia

Enrollment

134 participants

Start Date

Oct 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 DayMax Age: 3 Days

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Caffeine citrate and Placebo for people with prematurity, respiratory disease, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCaffeine 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)

OTHERPlacebo

Equivalent volume of saline


Locations(2)

King Salman Bin Abdulaziz Medical City

Madinah, Medina Region, Saudi Arabia

King Salman Bin Abdulaziz Medical City

Madinah, Saudi Arabia

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NCT06026163


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