The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate

What this Trial Is About

Researchers are studying whether giving a single additional loading dose of caffeine citrate one hour before extubation improves the success rate of extubation in preterm infants born before the 32nd week of gestation. The study also aims to evaluate how this intervention affects the frequency of apnea episodes, side effects, and the development of complications such as necrotizing enterocolitis, bronchopulmonary dysplasia, intraventricular hemorrhage, periventricular leukomalacia, and long-term neurodevelopmental outcomes. Participants include preterm neonates who have been mechanically ventilated for at least 48 hours before a planned extubation. They will be randomly assigned to one of two groups: one will receive an additional intravenous loading dose of 20 mg/kg caffeine citrate 60 minutes before extubation, while the other group will continue with the standard caffeine dosing regimen, which includes a loading dose on the first day of life and a maintenance dose of 5-10 mg/kg daily. The trial will be conducted in neonatal intensive care units and includes careful stratification by gestational age and antenatal steroid use. During the study, researchers will monitor the need for reintubation within 48 hours after extubation as the primary outcome. They will also track secondary outcomes such as apnea frequency, heart rate changes, tachycardia, gastric residual volume, feeding reduction, blood pressure changes, days on mechanical or non-invasive ventilation, and rates of common complications in prematurity up to discharge or specific timepoints. Long-term neurodevelopmental outcomes will be assessed at two years of corrected age. Safety and side effects will be carefully observed throughout the study period.

The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate