Journal article
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, Vol.229, pp.127-133
02/2021
DOI: 10.1016/j.jpeds.2020.10.024
PMID: 33069668
Abstract
To evaluate 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 to characterize challenges in obtaining consent, compliance with the protocol, and PDA closure rates.
This single-center, randomized control pilot study of 60 infants <29 weeks of gestation with a high PDAsc (≥5.0) at 36-48 hours of age receiving either ibuprofen or placebo intravenously. The study protocol did not allow for additional PDA therapy within the first 2 weeks. We reported the rate of consent, open label treatment, and PDA closure rates. The primary outcome was chronic lung disease or death.
We approached 83 families for enrollment with 73 (88%) providing consent; 13 infants had a PDAsc of <5; of the remaining infants, 30 were assigned ibuprofen and 30 received placebo. Eight infants received open label treatment in the first 2 weeks (12%). The overall PDA closure rate after treatment was 57% in the intervention group and 17% in the control group (P < .01). There was no difference in the primary clinical outcome (OR, 0.8; 95% CI, 0.3-2.1).
Using a PDAsc for infant recruitment to a PDA treatment randomized controlled trial is feasible. There is a high rate of consent and relatively low rate of open-label PDA treatment. The overall PDA closure rate in the intervention arm was low placing the emphasis on devising more effective PDA closure strategies in future randomized controlled trials.
ISRCTN (13281214) and European Union Drug Regulating Authorities Clinical Trials Database (2015-004526-33).
Details
- Title: Subtitle
- A Pilot Randomized Controlled Trial of Early Targeted Patent Ductus Arteriosus Treatment Using a Risk Based Severity Score (The PDA RCT)
- Creators
- Afif EL-Khuffash - Rotunda HospitalNeidín Bussmann - Rotunda HospitalColm R. Breatnach - Rotunda HospitalAisling Smith - Rotunda HospitalElizabeth Tully - Royal College of Surgeons in IrelandJoanna Griffin - Rotunda HospitalNaomi McCallion - Rotunda HospitalJohn David Corcoran - Rotunda HospitalElena Fernandez - Rotunda HospitalClaudia Looi - Rotunda HospitalBrian Cleary - Royal College of Surgeons in IrelandOrla Franklin - Our Lady's HospitalPatrick J. McNamara - University of Iowa
- Resource Type
- Journal article
- Publication Details
- The Journal of pediatrics, Vol.229, pp.127-133
- Publisher
- Elsevier Inc
- DOI
- 10.1016/j.jpeds.2020.10.024
- PMID
- 33069668
- ISSN
- 0022-3476
- eISSN
- 1097-6833
- Grant note
- RPAC 16-03 / Temple Street Hospital Foundation
- Language
- English
- Date published
- 02/2021
- Academic Unit
- Stead Family Department of Pediatrics; Neonatology; Internal Medicine
- Record Identifier
- 9984353832102771
Metrics
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