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

What this Trial Is About

Researchers are evaluating the use of caffeine citrate in late-preterm infants who experience respiratory distress. The study aims to understand whether caffeine can improve breathing effort, reduce apnea episodes, shorten hospital stays, and improve alertness in babies born between 34 and 36 6/7 weeks of gestation. This is a controlled trial comparing caffeine therapy to placebo in this vulnerable population. Participants are randomly assigned to receive either caffeine citrate or a placebo in a double-blind manner. The caffeine group receives a loading dose of 20 mg/kg (equivalent to 10 mg/kg caffeine base) followed by a maintenance dose of 10 mg/kg/day (equivalent to 5 mg/kg caffeine base). Treatment continues until the infant no longer needs any respiratory support. The placebo group receives an equivalent volume of saline. Preparation and administration of the study drugs are handled by a pharmacist not involved in the study to maintain blinding. During the 28-day study period, infants will be closely monitored for duration of respiratory support, episodes and days of apnea, extubation failure, length of hospital stay, feeding progress, weight gain, and any adverse effects from caffeine use. Researchers will also track readmission rates and mortality. Assessments include clinical observations and routine care measures to evaluate the overall impact of caffeine on respiratory health and recovery in late-preterm infants.

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