Professor of Pediatrics Saint Louis University School of Medicine Saint Louis, Missouri, United States
Background: Early caffeine became a standard of care for prematurely born newborns. The standard of care was based upon large retrospective database studies rather than randomized double blind controlled trials. Objective: Primary objective of this study is to test the hypothesis that early caffeine given within 24 hours of life will decrease incidence of mortality, Bronchopulmonary Dysplasia (BPD) in ventilated extremely preterm newborns born at ≤28 weeks gestation. Design/Methods: A multi-center double blind randomized controlled trial was performed. One hundred and ten extremely preterm newborns were enrolled at ≤28 weeks gestation. Enrolled newborns received either 20 mg/kg of caffeine or placebo within first 24 hours of life. The study drug/place bo was continued at 5 mg/kg of caffeine or placebo for 14 days. The primary outcome variable was a composite outcome of death or BPD as evaluated by physiological definition of BPD at 36 weeks corrected gestational age. Data was analyzed using intention to treat analyses. Results: Fifty eight newborns received the study drug and 52 newborns received placebo. Difference between in hospital mortality, BPD, Necrotizing enterocolitis (NEC), Retinopathy (ROP), patent ductus arteriosus PDA was not statistically significantly different in newborns in early caffeine versus placebo group. Percentage of newborns with the composite outcome of death or BPD was not statistically significantly (p= 0.55) different in newborns that received early caffeine [30/53 (56.6%0] versus placebo [32/51(62.7%)].
Conclusion(s): Early caffeine given within 24 hours was not associated with improved composite outcomes of death or BPD in a small randomized double blind controlled trial.
