Martin Kluckow1, Hazel Carlisle2, Margaret Broom2, Patricia Woods3, Michele Jeffery4, Deepa Desai4, Yan Chen4, Nick Evans3. 1. Department of Neonatology, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia. martin.kluckow@sydney.edu.au. 2. The Canberra Hospital, Canberra, ACT, Australia. 3. Royal Prince Alfred Women and Babies Hospital and University of Sydney, Sydney, NSW, Australia. 4. Department of Neonatology, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia.
Abstract
OBJECTIVE: To explore the efficacy and risks of oral paracetamol in later (>2 weeks old) treatment of patent ductus arteriosus (PDA). STUDY DESIGN: A multicentre double-blind placebo-controlled randomised pilot trial in three neonatal intensive care units in Australia. Infants born <33 weeks with haemodynamically significant PDA were treated with a 5-day course of oral paracetamol or placebo. Cardiac ultrasounds were used to document haemodynamic parameters. The primary outcome analysed was ductal closure by 48 h after treatment completion. Secondary outcomes included reduction in ductal diameter >25% and safety. RESULTS:Fifty-five infants were enrolled, of whom 27 receivedparacetamol and 28 placebo. Eighty percent had received previous non-steroidal anti-inflammatory drug. Mean postnatal age was 25 days. Four of the 27 ducts treated with paracetamol closed vs. 0/28 treated with placebo (p = 0.05). An additional 13/27 given paracetamol vs. 7/28 given placebo showed significant constriction (p = 0.008). No adverse effects were observed . CONCLUSIONS: There was some evidence of increased closure with oral paracetamol at postnatal age >2 weeks; however, the overall efficacy was not high.
RCT Entities:
OBJECTIVE: To explore the efficacy and risks of oral paracetamol in later (>2 weeks old) treatment of patent ductus arteriosus (PDA). STUDY DESIGN: A multicentre double-blind placebo-controlled randomised pilot trial in three neonatal intensive care units in Australia. Infants born <33 weeks with haemodynamically significant PDA were treated with a 5-day course of oral paracetamol or placebo. Cardiac ultrasounds were used to document haemodynamic parameters. The primary outcome analysed was ductal closure by 48 h after treatment completion. Secondary outcomes included reduction in ductal diameter >25% and safety. RESULTS: Fifty-five infants were enrolled, of whom 27 received paracetamol and 28 placebo. Eighty percent had received previous non-steroidal anti-inflammatory drug. Mean postnatal age was 25 days. Four of the 27 ducts treated with paracetamol closed vs. 0/28 treated with placebo (p = 0.05). An additional 13/27 given paracetamol vs. 7/28 given placebo showed significant constriction (p = 0.008). No adverse effects were observed . CONCLUSIONS: There was some evidence of increased closure with oral paracetamol at postnatal age >2 weeks; however, the overall efficacy was not high.
Authors: Leeann R Pavlek; Brian K Rivera; Charles V Smith; Joanie Randle; Cory Hanlon; Kristi Small; Edward F Bell; Matthew A Rysavy; Sara Conroy; Carl H Backes Journal: J Pediatr Date: 2021-04-21 Impact factor: 6.314