TY - JOUR
T1 - Low dose paracetamol for management of patent ductus arteriosus in very preterm infants
T2 - a randomised non-inferiority trial
AU - Balasubramanian, Haribalakrishna
AU - Jain, Vaibhav
AU - Bhalgat, Parag
AU - Parikh, Shalin
AU - Kabra, Nandkishore
AU - Mohan, Diwakar
AU - Sheth, Kshitij
N1 - Funding Information:
The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Publisher Copyright:
© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023/3
Y1 - 2023/3
N2 - Objective To compare the efficacy of low dose-short course intravenous paracetamol with a conventional dose regimen for early targeted closure of patent ductus arteriosus (PDA). Design Single-centre, double-blinded, active controlled, randomised non-inferiority trial. Setting Level III neonatal intensive care unit in Western India. Patients Preterm infants <30 weeks of gestation requiring mechanical ventilation, or continuous positive airway pressure with FiO2 ≥0.35 and diagnosed with a haemodynamically significant PDA (hsPDA) at 18-24 hours of postnatal age. Interventions Low dose (10 mg/kg/dose 6 hourly for 72 hours) versus conventional dose (15 mg/kg/dose 6 hourly for 120 hours) intravenous paracetamol treatment. Main outcome measures Comparison of the rates of ductal closure at completion of sixth postnatal day, using a prespecified non-inferiority margin of 20%. Results A total of 102 infants were enrolled. The median gestational age and birth weight of the included infants were 26.4 weeks and 830 g. At completion of the sixth postnatal day, closure of PDA was achieved in 92% of infants in the low dose group as compared with 94% of those in the standard dose group (risk difference: -1.6%, 95% CI: -11.6% to 8.5%, p=0.38). The rates of rescue therapies, adverse effects and other neonatal morbidities were comparable in both groups. Conclusion In very preterm infants on significant respiratory support, low dose-short course intravenous paracetamol treatment was non-inferior to a conventional dosing regime of paracetamol for closure of hsPDA in the first week of postnatal age. Larger studies with narrow margins of non-inferiority are required to confirm our findings.
AB - Objective To compare the efficacy of low dose-short course intravenous paracetamol with a conventional dose regimen for early targeted closure of patent ductus arteriosus (PDA). Design Single-centre, double-blinded, active controlled, randomised non-inferiority trial. Setting Level III neonatal intensive care unit in Western India. Patients Preterm infants <30 weeks of gestation requiring mechanical ventilation, or continuous positive airway pressure with FiO2 ≥0.35 and diagnosed with a haemodynamically significant PDA (hsPDA) at 18-24 hours of postnatal age. Interventions Low dose (10 mg/kg/dose 6 hourly for 72 hours) versus conventional dose (15 mg/kg/dose 6 hourly for 120 hours) intravenous paracetamol treatment. Main outcome measures Comparison of the rates of ductal closure at completion of sixth postnatal day, using a prespecified non-inferiority margin of 20%. Results A total of 102 infants were enrolled. The median gestational age and birth weight of the included infants were 26.4 weeks and 830 g. At completion of the sixth postnatal day, closure of PDA was achieved in 92% of infants in the low dose group as compared with 94% of those in the standard dose group (risk difference: -1.6%, 95% CI: -11.6% to 8.5%, p=0.38). The rates of rescue therapies, adverse effects and other neonatal morbidities were comparable in both groups. Conclusion In very preterm infants on significant respiratory support, low dose-short course intravenous paracetamol treatment was non-inferior to a conventional dosing regime of paracetamol for closure of hsPDA in the first week of postnatal age. Larger studies with narrow margins of non-inferiority are required to confirm our findings.
KW - cardiology
KW - neonatology
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U2 - 10.1136/archdischild-2022-323781
DO - 10.1136/archdischild-2022-323781
M3 - Article
C2 - 35940873
AN - SCOPUS:85136537559
SN - 1359-2998
VL - 108
SP - 130
EP - 135
JO - Archives of Disease in Childhood: Fetal and Neonatal Edition
JF - Archives of Disease in Childhood: Fetal and Neonatal Edition
IS - 2
ER -