Variation in the definition of pulmonary hypertension and clinical indications for the use of nitric oxide in neonatal clinical trials.

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.

Quality improvement programme to improve compliance with initial respiratory support guideline at preterm birth.

AIM: CPAP (continuous airway pressure) use as respiratory support from birth increases the proportion of babies who survive without bronchopulmonary dysplasia. Although we introduced a guideline for CPAP use in 2015, our intubation rate remained high (61.7%). We aimed to reduce the intubation rate into the interquartile range for the Vermont Oxford Neonatal (VON) network. METHODS: A multi-disciplinary team was established. Data relating to resuscitation in all babies born before 32 weeks gestation or with a birth weight below 1500 g during 2017/2018 were collected prospectively. Episodes when CPAP was not used were identified, and series of Plan, Do, See, Act (PDSA) cycles performed. Performance data were displayed graphically to staff along with lessons learnt. RESULTS: The rate of intubation at birth for VLBW babies fell from 61.7% into the VON interquartile range at 49.6% during the project (P = .02). Intubation rate in babies born between 26 and 30 weeks gestation fell from 66% to 41% (the VON network mean). CONCLUSION: The NICU is a complex system. Altering clinical practice is challenging, even with good clinical evidence to support change. Quality improvement using frequent PDSA cycles enabled us to alter our practice. Preterm intubation rates are now within the desired range.