Cerebral Oximetry Monitoring in Extremely Preterm Infants.
Humans
Infant
Infant, Newborn
Brain Injuries
/ diagnostic imaging
Bronchopulmonary Dysplasia
/ etiology
Cerebrovascular Circulation
Infant, Extremely Premature
Infant, Premature, Diseases
/ diagnosis
Oximetry
/ methods
Cerebrum
Ultrasonography
Retinopathy of Prematurity
/ etiology
Enterocolitis, Necrotizing
/ etiology
Neonatal Sepsis
/ etiology
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
20 Apr 2023
20 Apr 2023
Historique:
medline:
21
4
2023
pubmed:
19
4
2023
entrez:
19
04
2023
Statut:
ppublish
Résumé
The use of cerebral oximetry monitoring in the care of extremely preterm infants is increasing. However, evidence that its use improves clinical outcomes is lacking. In this randomized, phase 3 trial conducted at 70 sites in 17 countries, we assigned extremely preterm infants (gestational age, <28 weeks), within 6 hours after birth, to receive treatment guided by cerebral oximetry monitoring for the first 72 hours after birth or to receive usual care. The primary outcome was a composite of death or severe brain injury on cerebral ultrasonography at 36 weeks' postmenstrual age. Serious adverse events that were assessed were death, severe brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and late-onset sepsis. A total of 1601 infants underwent randomization and 1579 (98.6%) were evaluated for the primary outcome. At 36 weeks' postmenstrual age, death or severe brain injury had occurred in 272 of 772 infants (35.2%) in the cerebral oximetry group, as compared with 274 of 807 infants (34.0%) in the usual-care group (relative risk with cerebral oximetry, 1.03; 95% confidence interval, 0.90 to 1.18; P = 0.64). The incidence of serious adverse events did not differ between the two groups. In extremely preterm infants, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth was not associated with a lower incidence of death or severe brain injury at 36 weeks' postmenstrual age than usual care. (Funded by the Elsass Foundation and others; SafeBoosC-III ClinicalTrials.gov number, NCT03770741.).
Sections du résumé
BACKGROUND
BACKGROUND
The use of cerebral oximetry monitoring in the care of extremely preterm infants is increasing. However, evidence that its use improves clinical outcomes is lacking.
METHODS
METHODS
In this randomized, phase 3 trial conducted at 70 sites in 17 countries, we assigned extremely preterm infants (gestational age, <28 weeks), within 6 hours after birth, to receive treatment guided by cerebral oximetry monitoring for the first 72 hours after birth or to receive usual care. The primary outcome was a composite of death or severe brain injury on cerebral ultrasonography at 36 weeks' postmenstrual age. Serious adverse events that were assessed were death, severe brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and late-onset sepsis.
RESULTS
RESULTS
A total of 1601 infants underwent randomization and 1579 (98.6%) were evaluated for the primary outcome. At 36 weeks' postmenstrual age, death or severe brain injury had occurred in 272 of 772 infants (35.2%) in the cerebral oximetry group, as compared with 274 of 807 infants (34.0%) in the usual-care group (relative risk with cerebral oximetry, 1.03; 95% confidence interval, 0.90 to 1.18; P = 0.64). The incidence of serious adverse events did not differ between the two groups.
CONCLUSIONS
CONCLUSIONS
In extremely preterm infants, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth was not associated with a lower incidence of death or severe brain injury at 36 weeks' postmenstrual age than usual care. (Funded by the Elsass Foundation and others; SafeBoosC-III ClinicalTrials.gov number, NCT03770741.).
Identifiants
pubmed: 37075142
doi: 10.1056/NEJMoa2207554
doi:
Banques de données
ClinicalTrials.gov
['NCT03770741']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1501-1511Subventions
Organisme : Aage og Johanne Louis-Hansens Fond
ID : 20-2B-5935
Organisme : Svend Andersen Fonden
ID : No grant number
Organisme : Elsass Fonden
ID : 18-3-0133
Organisme : Elsass Fonden
ID : 20-3-0985
Informations de copyright
Copyright © 2023 Massachusetts Medical Society.