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Effect of Prophylactic Caffeine on Noninvasive Respiratory Support in Preterm Neonates Weighing 1250-2000 g: A Randomized Controlled Trial.

BACKGROUND
Caffeine is commonly used to prevent or treat apnea in preterm neonates. The present trial was designed to determine the effect of caffeine on reducing the time required for nasal continuous positive airway pressure (NCPAP) in neonates with respiratory distress syndrome (RDS).


METHODS
In a randomized controlled trial, a total of 90 neonates (birth weight between 1250 and 2000 g) who were clinically diagnosed with RDS were subjected to random assignment to one of the two groups of caffeine (n=45) or control (n=45). Infants in the caffeine group received 20 mg/kg caffeine as the initial dose, and then 10 mg/kg daily as the maintenance dose. Infants in the control group did not receive any placebo or similar drugs. The primary outcome was the duration time of respiratory support with NCPAP.


RESULTS
The mean (SD) duration of NCPAP differed significantly and was shorter among the infants in the caffeine group than those assigned to the control group (41.53 (43.25) versus 78.48 (114.25) hours, respectively; mean difference: -36.95; 95%CI: -73.14, -0.76; P = 0.04). Apnea of prematurity (AOP) occurred in 2 (4.4%) newborns in the caffeine group and in 9 (20%) of the infants in the control condition [proportion difference: -15.6% (-29.8,-1.8); (P = 0.02)]. The incidence of intraventricular hemorrhage (IVH) was higher in the control group than in the caffeine group after one week (P = 0.03). The incidence of chronic lung disease (CLD), infection, necrotizing enterocolitis (NEC), seizure, vomiting and pneumothorax was similar in the two groups.


CONCLUSION
The results suggest that preventative caffeine can reduce the duration of NCPAP support in neonates with RDS.