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Variation in the definition of pulmonary hypertension and clinical indications for the use of nitric oxide in neonatal clinical trials
Author(s) -
Hoyle Emily S.,
Slee Samantha L.,
Subhedar Nimish V.
Publication year - 2020
Publication title -
acta paediatrica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.772
H-Index - 115
eISSN - 1651-2227
pISSN - 0803-5253
DOI - 10.1111/apa.15058
Subject(s) - medicine , pulmonary hypertension , clinical trial , respiratory failure , randomized controlled trial , respiratory system , pediatrics , intensive care medicine
Aim Pulmonary hypertension (PH) frequently complicates neonatal hypoxaemic respiratory failure, but is inconsistently defined. We aimed to describe the variation among randomised controlled trials (RCTs) of inhaled nitric oxide (iNO), in relation to the definition of PH and/or hypoxaemic respiratory failure used to select patients for trial inclusion. Methods PubMed, Cochrane Library and ClinicalTrials.gov were systematically searched for RCTs of iNO in neonates. Included studies were assessed for clinical and/or echocardiography criteria used to define PH/hypoxaemic respiratory failure. Results Thirty‐two trials were included in this review, of which 23 enrolled infants ≥34 weeks’ gestation. Echocardiographic diagnosis was used in 21 studies, but there was considerable variation in the echocardiographic parameters used to diagnose PH. The most commonly used indices included markers of tricuspid regurgitation and extrapulmonary shunt. Conclusion There is wide variation in the definition of PH used to select infants for inclusion into RCTs of iNO therapy in neonates. We recommend that an international consensus be reached on which parameters should be used and the thresholds defining severity of disease.