Survival and Neurodevelopmental Outcomes of Preterms Resuscitated With Different Oxygen Fractions

• Published in: Pediatrics (Evanston) Vol. 138; no. 6; p. 1
• Main Authors: Boronat, Nuria, Aguar, Marta, Rook, Denise, Iriondo, Martin, Brugada, María, Cernada, María, Nuñez, Antonio, Izquierdo, Montserrat, Cubells, Elena, Martinez, María, Parra, Anna, van Goudoever, Hans, Vento, Máximo
• Format: Journal Article
• Language: English
• Published: United States American Academy of Pediatrics 01-12-2016
• Subjects: Analysis; Babies; Child Development; Child, Preschool; Clinical trials; Development; Developmental biology; Double-Blind Method; Female; Gestational Age; Health aspects; Humans; Incubators (Pediatrics); Infant; Infant development; Infant, Extremely Premature; Infant, Newborn; Infant, Premature; Infants; Infants (Premature); Male; Netherlands; Neurodevelopmental Disorders - epidemiology; Oxidative stress; Oxygen consumption; Oxygen consumption (Metabolism); Oxygen Inhalation Therapy - adverse effects; Oxygen Inhalation Therapy - methods; Pediatrics; Premature infants; Resuscitation - adverse effects; Resuscitation - methods; Spain; Survival analysis; Survival Rate; Survival skills; Ventilators; Netherlands; Spain
• ISSN: 0031-4005; 1098-4275
• DOI: 10.1542/peds.2016-1405

Stabilization of preterm infants after birth frequently requires oxygen supplementation. At present the optimal initial oxygen inspiratory fraction (Fio
) for preterm stabilization after birth is still under debate. We aimed to compare neurodevelopmental outcomes of extremely preterm infants at 24 months corrected age randomly assigned to be stabilized after birth with an initial Fio
of 0.3 versus 0.6 to 0.65 in 3 academic centers from Spain and the Netherlands.
Randomized, controlled, double-blinded, multicenter, international clinical trial enrolling preterm infants <32 weeks' gestation assigned to an initial Fio
of 0.3 (Lowox group) or 0.6 to 0.65 (Hiox group). During stabilization, arterial pulse oxygen saturation and heart rate were continuously monitored and Fio
was individually titrated to keep infants within recommended ranges. At 24 months, blinded researchers used the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) to assess visual acuity, neurosensory deafness, and language skills.
A total of 253 infants were recruited and 206 (81.4%) completed follow-up. No differences in perinatal characteristics, oxidative stress, or morbidities during the neonatal period were assessed. Mortality at hospital discharge or when follow-up was completed didn't show differences between the groups. No differences regarding Bayley-III scale scores (motor, cognitive, and language composites), neurosensorial handicaps, cerebral palsy, or language skills between groups were found.
The use of an initial lower (0.3) or higher (0.6-0.65) Fio
during stabilization of extremely preterm infants in the delivery room does not influence survival or neurodevelopmental outcomes at 24 months.