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Background: A respiratory function monitor (RFM) gives immediate feedback, allowing clinicians to adjust face mask ventilation to correct leak or inappropriate tidal volumes. We audited the satisfaction of clinicians with a neonatal resuscitation training package, incorporating a novel RFM. Methods: This was a mixed-methods study conducted at The Royal Women's Hospital, Melbourne, Australia. Clinicians were approached to complete a neonatal resuscitation training session. Participants watched a training video, then provided ventilation to term and preterm manikins first without, and then with, the RFM. Clinicians completed a survey after the session and undertook a follow-up session three months later. The primary outcome was participant satisfaction with the RFM. Secondary outcomes included participants' self-assessment of face mask leak and tidal volumes when using the RFM. Results: Fifty clinicians completed both the initial and follow-up session. Participants reported high levels of satisfaction with the RFM for both term and preterm manikins: on a scale from 0, meaning "not at all", and 100, meaning "yes, for all resuscitations", the median response (interquartile range, IQR) was 82 (74-94) vs 81.5 (69-94.5). Levels of satisfaction were similar for less experienced and more experienced clinicians: median (IQR) 83 (77-93) vs 81 (71.5-95) respectively. When using the monitor, clinicians accurately self-assessed that they achieved leak below 30% and tidal volumes within the target range at least 80% of the time. Conclusion: Clinicians of all experience levels had a high level of satisfaction with a training package including a novel RFM.
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BACKGROUND: Surfactant is a well-established therapy for preterm neonates affected by respiratory distress syndrome (RDS). The goals of different methods of surfactant administration are to reduce the duration of mechanical ventilation and the severity of bronchopulmonary dysplasia (BPD); however, the optimal administration method remains unknown. This study compares the effectiveness of the INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E) technique with the less-invasive surfactant administration (LISA) technique, in increasing BPD-free survival of preterm infants. This is an international unblinded multicenter randomized controlled study in which preterm infants will be randomized into two groups to receive IN-REC-SUR-E or LISA surfactant administration. METHODS: In this study, 382 infants born at 24+0-27+6 weeks' gestation, not intubated in the delivery room and failing nasal continuous positive airway pressure (nCPAP) or nasal intermittent positive pressure ventilation (NIPPV) during the first 24 h of life, will be randomized 1:1 to receive IN-REC-SUR-E or LISA surfactant administration. The primary outcome is a composite outcome of death or BPD at 36 weeks' postmenstrual age. The secondary outcomes are BPD at 36 weeks' postmenstrual age; death; pulse oximetry/fraction of inspired oxygen; severe intraventricular hemorrhage; pneumothorax; duration of respiratory support and oxygen therapy; pulmonary hemorrhage; patent ductus arteriosus undergoing treatment; percentage of infants receiving more doses of surfactant; periventricular leukomalacia, severe retinopathy of prematurity, necrotizing enterocolitis, sepsis; total in-hospital stay; systemic postnatal steroids; neurodevelopmental outcomes; and respiratory function testing at 24 months of age. Randomization will be centrally provided using both stratification and permuted blocks with random block sizes and block order. Stratification factors will include center and gestational age (24+0 to 25+6 weeks or 26+0 to 27+6 weeks). Analyses will be conducted in both intention-to-treat and per-protocol populations, utilizing a log-binomial regression model that corrects for stratification factors to estimate the adjusted relative risk (RR). DISCUSSION: This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24+0-27+6 weeks' gestation affected by RDS and failing nCPAP or NIPPV during the first 24 h of life, comparing IN-REC-SUR-E to LISA technique, in increasing BPD-free survival at 36 weeks' postmenstrual age of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT05711966. Registered on February 3, 2023.