Show simple item record

dc.contributor.authorMurphy, Madeleine C.
dc.contributor.authorMiletin, Jan
dc.contributor.authorKlingenberg, Claus Andreas
dc.contributor.authorGuthe, Hans Jørgen Timm
dc.contributor.authorRigo, Vincent
dc.contributor.authorPlavka, Richard
dc.contributor.authorBohlin, Kajsa
dc.contributor.authorBarroso Pereira, Almerinda
dc.contributor.authorJuren, Tomáš
dc.contributor.authorAlih, Ekele
dc.contributor.authorGalligan, Marie
dc.contributor.authorO'Donnell, Colm P. F.
dc.date.accessioned2024-02-29T09:25:34Z
dc.date.available2024-02-29T09:25:34Z
dc.date.issued2023-12-11
dc.description.abstractImportance - 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.<p> <p>Objective - To assess whether giving prophylactic oropharyngeal surfactant to preterm newborns at birth would reduce the rate of intubation for respiratory failure.<p> <p>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.<p> <p>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).<p> <p>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.<p> <p>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).<p> <p>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.en_US
dc.identifier.citationMurphy, Miletin, Klingenberg, Guthe, Rigo, Plavka, Bohlin, Barroso Pereira, Juren, Alih, Galligan, O'Donnell. Prophylactic Oropharyngeal Surfactant for Preterm Newborns at Birth: A Randomized Clinical Trial. JAMA pediatrics. 2023(178(2))en_US
dc.identifier.cristinIDFRIDAID 2243172
dc.identifier.doi10.1001/jamapediatrics.2023.5082
dc.identifier.issn2168-6203
dc.identifier.issn2168-6211
dc.identifier.urihttps://hdl.handle.net/10037/33081
dc.language.isoengen_US
dc.publisherAmerican Medical Associationen_US
dc.relation.journalJAMA pediatrics
dc.relation.projectIDinfo:eu-repo/grantAgreement/EC/H2020/731046/France/Paediatric Clinical Research Infrastructure Network/PedCRIN/en_US
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2023 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by/4.0en_US
dc.rightsAttribution 4.0 International (CC BY 4.0)en_US
dc.titleProphylactic Oropharyngeal Surfactant for Preterm Newborns at Birth: A Randomized Clinical Trialen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


File(s) in this item

Thumbnail

This item appears in the following collection(s)

Show simple item record

Attribution 4.0 International (CC BY 4.0)
Except where otherwise noted, this item's license is described as Attribution 4.0 International (CC BY 4.0)