Survival and Neurodevelopmental Outcomes of Preterms Resuscitated With Different Oxygen Fractions
Nuria Boronat1, Marta Aguar1, Denise Rook2
1Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain.
Insights
The initial oxygen concentration (Fio2) used for stabilizing extremely preterm infants does not impact survival or neurodevelopmental outcomes at 24 months corrected age. Both low (0.3) and high (0.6-0.65) initial Fio2 levels showed similar results in this clinical trial.
Area of Science:
- Neonatal Medicine
- Pediatric Neurology
- Clinical Trials
Background:
- Stabilization of preterm infants often requires oxygen supplementation.
- The optimal initial oxygen inspiratory fraction (Fio2) for preterm infant stabilization is debated.
- This study addresses the impact of initial Fio2 on neurodevelopmental outcomes.
Purpose of the Study:
- To compare neurodevelopmental outcomes at 24 months corrected age.
- To evaluate infants randomly assigned to initial Fio2 of 0.3 versus 0.6-0.65.
- To assess outcomes in extremely preterm infants.
Main Methods:
- Randomized, controlled, double-blinded, multicenter international clinical trial.
- Infants <32 weeks gestation assigned to initial Fio2 of 0.3 (Lowox) or 0.6-0.65 (Hiox).
- Neurodevelopmental assessment using Bayley Scales of Infant and Toddler Development (Bayley-III) at 24 months.
Main Results:
- 253 infants recruited, 206 completed follow-up; no differences in perinatal characteristics or neonatal morbidities.
- No significant differences in mortality between groups at hospital discharge or follow-up completion.
- No differences in Bayley-III scores, neurosensory handicaps, cerebral palsy, or language skills between groups.
Conclusions:
- Initial lower (0.3) or higher (0.6-0.65) Fio2 during delivery room stabilization does not influence survival.
- Neurodevelopmental outcomes at 24 months are not affected by the initial Fio2 used.
- The choice of initial Fio2 for preterm infant stabilization has no long-term impact on key developmental milestones.
Background And Objectives:
Stabilization of preterm infants after birth frequently requires oxygen supplementation. At present the optimal initial oxygen inspiratory fraction (Fio2) 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 Fio2 of 0.3 versus 0.6 to 0.65 in 3 academic centers from Spain and the Netherlands.
Methods:
Randomized, controlled, double-blinded, multicenter, international clinical trial enrolling preterm infants <32 weeks' gestation assigned to an initial Fio2 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 Fio2 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.
Results:
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.
Conclusions:
The use of an initial lower (0.3) or higher (0.6-0.65) Fio2 during stabilization of extremely preterm infants in the delivery room does not influence survival or neurodevelopmental outcomes at 24 months.
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