Pediatrics, Perinatology and Child Health; preterm infant; surfactant; birth
Abstract :
[en] [en] IMPORTANCE: Preterm newborns at risk of respiratory distress syndrome are supported with continuous positive airway pressure (CPAP). Many newborns worsen despite CPAP and are intubated for surfactant administration, an effective therapy for treatment of respiratory distress syndrome. Endotracheal intubation is associated with adverse effects. Pharyngeal administration of surfactant to preterm animals and humans has been reported as an alternative.
OBJECTIVE: To assess whether giving prophylactic oropharyngeal surfactant to preterm newborns at birth would reduce the rate of intubation for respiratory failure.
DESIGN, SETTING, AND PARTICIPANTS: This unblinded, parallel-group randomized clinical trial (Prophylactic Oropharyngeal Surfactant for Preterm Infants [POPART]) was conducted from December 17, 2017, to September 11, 2020, at 9 tertiary neonatal intensive care units in 6 European countries. Newborns born before 29 weeks of gestation without severe congenital anomalies, for whom intensive care was planned, were eligible for inclusion. The data were analyzed from July 27, 2022, to June 20, 2023.
INTERVENTION: Newborns were randomly assigned to receive oropharyngeal surfactant at birth in addition to CPAP or CPAP alone. Randomization was stratified by center and gestational age (GA).
MAIN OUTCOMES AND MEASURES: The primary outcome was intubation in the delivery room for bradycardia and/or apnea or in the neonatal intensive care unit for prespecified respiratory failure criteria within 120 hours of birth. Caregivers were not masked to group assignment.
RESULTS: Among 251 participants (mean [SD] GA, 26 [1.5] weeks) who were well matched at study entry, 126 (69 [54.8%] male) with a mean (SD) birth weight of 858 (261) grams were assigned to the oropharyngeal surfactant group, and 125 (63 [50.4%] male) with a mean (SD) birth weight of 829 (253) grams were assigned to the control group. The proportion of newborns intubated within 120 hours was not different between the groups (80 [63.5%) in the oropharyngeal surfactant group and 81 [64.8%] in the control group; relative risk, 0.98 [95% CI, 0.81-1.18]). More newborns assigned to the oropharyngeal surfactant group were diagnosed with and treated for pneumothorax (21 [16.6%] vs 8 [6.4%]; P = .04).
CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that administration of prophylactic oropharyngeal surfactant to newborns born before 29 weeks' GA did not reduce the rate of intubation in the first 120 hours of life. These findings suggest that administration of surfactant into the oropharynx immediately after birth in addition to CPAP should not be routinely used.
TRIAL REGISTRATION: EudraCT: 2016-004198-41.
Disciplines :
Pediatrics
Author, co-author :
Murphy, Madeleine C; National Maternity Hospital, Dublin, Ireland ; School of Medicine, University College Dublin, Dublin, Ireland ; National Children's Research Centre, Dublin, Ireland
Miletin, Jan; Coombe Women and Infants University Hospital, Dublin, Ireland
Klingenberg, Claus; Paediatric Research Group, Faculty of Health Sciences, UiT-The Arctic University of Norway, Tromsø, Norway ; Department of Pediatrics and Adolescence Medicine, University Hospital of North Norway, Tromsø, Norway
Guthe, Hans Jørgen; Haukeland University Hospital, Bergen, Norway
Rigo, Vincent ; Centre Hospitalier Universitaire de Liège - CHU > > Service néonatologie (CHR) ; Université de Liège - ULiège > Département des sciences cliniques > Néonatologie
Plavka, Richard; Charles University, Prague, Czech Republic
Bohlin, Kajsa; Karolinska University Hospital, Stockholm, Sweden ; Karolinska Institutet, Stockholm, Sweden
Barroso Pereira, Almerinda; Hospital de Braga, Braga, Portugal
Juren, Tomáš; University Hospital Brno, Brno, Czech Republic
Alih, Ekele; School of Medicine, University College Dublin, Dublin, Ireland
Galligan, Marie; Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland
O'Donnell, Colm P F; National Maternity Hospital, Dublin, Ireland ; School of Medicine, University College Dublin, Dublin, Ireland
Language :
English
Title :
Prophylactic Oropharyngeal Surfactant for Preterm Newborns at Birth: A Randomized Clinical Trial.
Alternative titles :
[fr] Surfactant oropharyngé prophylactique chez le prématuré: un essai randomisé et contrôlé
European Union Framework Programme for Research and Innovation Horizon 2020 funded by
the Paediatric Clinical Research Infrastructure Network (PedCRIN); Chiesi (Chiesi Farmaceutici
supplied the study drug free of charge.); the National Children’s Research Centre (Dr Murphy).
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