A multi-centre randomised controlled trial of respiratory function monitoring during stabilisation of very preterm infants at birth

• DOI: 10.1016/j.resuscitation.2021.07.012
• Publication Date: 2021-07-22T08:29:45Z
• Authors: Henriëtte A. van ...; Kristel L.A.M. Ku...; Erik W van Zwet; Jeroen J. van Von...; C. Omar F. Kamlin; Laila Springer; Gianluca Lista; Francesco Cavigioli; Maximo Vento; Antonio Núñez-Ramiro; Andre Oberthuer; Angela Kribs; Helmut Kuester; Sebastian Horn; Danielle D. Weinberg; Elizabeth E. Foglia; Colin J. Morley; Peter G. Davis; Arjan B. te Pas
• Keywords: Periventricular leukomalacia; Respiratory Rate

AimTo determine whether the use of a respiratory function monitor (RFM) during PPV extremely preterm infants at birth, compared with no RFM, leads to an increase in percentage inflations expiratory tidal volume (Vte) within predefined target range.MethodsUnmasked, randomised clinical trial conducted October 2013 - May 2019 7 neonatal intensive care units 6 countries. Very (24–27 weeks gestation) receiving birth were have RFM screen visible or not. The primary outcome was median proportion manual (face mask intubated) range (Vte 4–8 mL/kg). There 42 other prespecified measurements and outcomes.ResultsAmong 288 (median (IQR) gestational age 26+2 (25+3–27+1) weeks), total number 51,352 analysed. group 30.0 (18.0–42.2)% vs 30.2 (14.8–43.1)% non-visible (p = 0.721). differences measurements, oxygen saturation, heart rate FiO2. outcomes, except for incidence intraventricular haemorrhage (all grades) and/or cystic periventricular leukomalacia (visible RFM: 26.7% 39.0%; RR 0.71 (0.68–0.97); p 0.028).ConclusionIn very as guidance delivery, did not range.Trial registrationDutch Trial Register NTR4104, clinicaltrials.gov NCT03256578.