Journal article
Early targeted patent ductus arteriosus treatment in premature neonates using a risk based severity score: study protocol for a randomised controlled trial (PDA RCT)
HRB open research, Vol.3, pp.87-87
11/25/2020
DOI: 10.12688/hrbopenres.13140.1
PMCID: PMC8422343
PMID: 34522836
Abstract
A patent ductus arteriosus (PDA) in preterm infants is associated with increased ventilator dependence and chronic lung disease, necrotizing enterocolitis, intraventricular haemorrhage, and poor neurodevelopmental outcome. Randomised controlled trials of early PDA treatment have not established a drop in the aforementioned morbidities. Those trials did not physiologically categorise PDA severity. Incorporating the specific physiological features of a haemodynamic significant PDA may evolve our understanding of this phenomenon, allowing accurate triaging using echocardiography and targeted treatment. Our group has recently demonstrated that a PDA severity score (PDAsc) derived at 36-48 hours of age can accurately predict the later occurrence of chronic lung disease or death (CLD/Death). Using echocardiography, we assessed PDA characteristics, as well as left ventricular diastolic function and markers of pulmonary overcirculation, and from this formulated a PDAsc. Gestation was also incorporated into the score. We hypothesise that in preterm infants at high risk of developing CLD/Death based on a PDAsc, early treatment with Ibuprofen compared with placebo will result in a reduction in CLD/Death. This is a single centre double-blind two arm randomised controlled trial conducted in the neonatal intensive care unit in the Rotunda Hospital, Dublin. Echocardiogram is carried out in the first 36-48 hours of life to identify preterm infants with a PDAsc ≥ 5.0 and these infants are randomised to Ibuprofen or placebo. Primary outcomes are assessed at 36 weeks post menstrual age. This pilot study’s purpose is to assess the feasibility of performing the trial and to obtain preliminary data to calculate a sample size for a definitive multi-centre trial of early PDA treatment using a PDAsc. We aim to recruit a total of 60 infants with a high risk PDA over three years.
Trial Registration:
ISRCTN
ISRCTN13281214
(26/07/2016) and the European Union Drug Regulating Authorities Clinical Trials Database
2015-004526-33
(03/12/2015).
Details
- Title: Subtitle
- Early targeted patent ductus arteriosus treatment in premature neonates using a risk based severity score: study protocol for a randomised controlled trial (PDA RCT)
- Creators
- Afif EL-Khuffash - Royal College of Surgeons in IrelandNeidin 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 - Rotunda HospitalOrla Franklin - Our Lady's HospitalPatrick J. McNamara - University of Iowa
- Resource Type
- Journal article
- Publication Details
- HRB open research, Vol.3, pp.87-87
- DOI
- 10.12688/hrbopenres.13140.1
- PMID
- 34522836
- PMCID
- PMC8422343
- NLM abbreviation
- HRB Open Res
- ISSN
- 2515-4826
- eISSN
- 2515-4826
- Publisher
- F1000 Research Limited
- Grant note
- National Children’s Research Centre RPAC16-03 / Temple Street Hospital Foundation NCHF-2017-005 / Health Research Board
- Language
- English
- Date published
- 11/25/2020
- Academic Unit
- Stead Family Department of Pediatrics; Neonatology; Internal Medicine
- Record Identifier
- 9984354383702771
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