Higher versus Lower Oxygen Concentration during Respiratory Support in the Delivery Room in Extremely Preterm Infants: A Pilot Feasibility Study.
delivery room
infant
neonatal resuscitation
newborn
oxygen concentration
Journal
Children (Basel, Switzerland)
ISSN: 2227-9067
Titre abrégé: Children (Basel)
Pays: Switzerland
ID NLM: 101648936
Informations de publication
Date de publication:
20 Oct 2021
20 Oct 2021
Historique:
received:
08
09
2021
revised:
07
10
2021
accepted:
15
10
2021
entrez:
27
11
2021
pubmed:
28
11
2021
medline:
28
11
2021
Statut:
epublish
Résumé
Optimal starting oxygen concentration for delivery room resuscitation of extremely preterm infants (<29 weeks) remains unknown, with recommendations of 21-30% based on uncertain evidence. Individual patient randomized trials designed to answer this question have been hampered by poor enrolment. It is feasible to compare 30% vs. 60% starting oxygen for delivery room resuscitation of extremely preterm infants using a change in local hospital policy and deferred consent approach. Prospective, single-center, feasibility study, with each starting oxygen concentration used for two months for all eligible infants. Infants born at 23 + 0-28 + 6 weeks' gestation who received delivery room resuscitation. Study interventions: Initial oxygen at 30% or 60%, increasing by 10-20% every minute for heart rate < 100 bpm, or increase to 100% for chest compressions. Feasibility, defined by (i) achieving difference in cumulative supplied oxygen concentration between groups, and (ii) post-intervention rate consent >50%. Thirty-four infants were born during a 4-month period; consent was obtained in 63%. Thirty ( Randomized control trial of 30% or 60% oxygen at the initiation of resuscitation of extremely preterm neonates with deferred consent is feasible. Clinicaltrials.gov NCT03706586.
Sections du résumé
BACKGROUND
BACKGROUND
Optimal starting oxygen concentration for delivery room resuscitation of extremely preterm infants (<29 weeks) remains unknown, with recommendations of 21-30% based on uncertain evidence. Individual patient randomized trials designed to answer this question have been hampered by poor enrolment.
HYPOTHESIS
OBJECTIVE
It is feasible to compare 30% vs. 60% starting oxygen for delivery room resuscitation of extremely preterm infants using a change in local hospital policy and deferred consent approach.
STUDY DESIGN
METHODS
Prospective, single-center, feasibility study, with each starting oxygen concentration used for two months for all eligible infants.
POPULATION
METHODS
Infants born at 23 + 0-28 + 6 weeks' gestation who received delivery room resuscitation. Study interventions: Initial oxygen at 30% or 60%, increasing by 10-20% every minute for heart rate < 100 bpm, or increase to 100% for chest compressions.
PRIMARY OUTCOME
METHODS
Feasibility, defined by (i) achieving difference in cumulative supplied oxygen concentration between groups, and (ii) post-intervention rate consent >50%.
RESULTS
RESULTS
Thirty-four infants were born during a 4-month period; consent was obtained in 63%. Thirty (
CONCLUSION
CONCLUSIONS
Randomized control trial of 30% or 60% oxygen at the initiation of resuscitation of extremely preterm neonates with deferred consent is feasible.
TRIAL REGISTRATION
BACKGROUND
Clinicaltrials.gov NCT03706586.
Identifiants
pubmed: 34828655
pii: children8110942
doi: 10.3390/children8110942
pmc: PMC8625238
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03706586']
Types de publication
Journal Article
Langues
eng
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