A pilot randomized controlled trial of early targeted patent ductus arteriosus treatment using a risk based severity score (The PDA RCT)
The Journal of Pediatrics Oct 20, 2020
EL-Khuffash A, Bussmann N, Breatnach CR, et al. - In this single center, randomized control pilot study, researchers assessed the feasibility of recruiting preterm infants to a randomized controlled trial of patent ductus arteriosus (PDA) treatment based on a PDA severity score (PDAsc) and described challenges in obtaining consent, compliance with the protocol, and PDA closure rates. The sample consisted of 60 infants < 29 weeks’ gestation with a high PDAsc (≥ 5.0) at 36–48 hours of age receiving either Ibuprofen or placebo intravenously. Data reported that the overall PDA closure rate after treatment was 57% in the Intervention Group and 17% in the Control Group. It is feasible to use a PDA severity score for infant recruitment to a PDA treatment RCT. There is a high consent rate and a comparatively low rate of open label PDA treatment. In the intervention arm, the overall PDA closure rate was poor, highlighting the devising more effective PDA closure strategies in future RCTs.
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