Nuria Boronat1, Marta Aguar1, Denise Rook2, Martin Iriondo3, María Brugada1, María Cernada4, Antonio Nuñez4, Montserrat Izquierdo3, Elena Cubells4, María Martinez4, Anna Parra1, Hans van Goudoever5, Máximo Vento6,4. 1. Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain. 2. Division of Neonatology, Sophia Children's Hospital, Erasmus Medical Center, Rotterdam, Netherlands. 3. Division of Neonatology, Hospital Sant Joan de Deu, Barcelona, Spain. 4. Neonatal Research Unit, Health Research Institute La Fe, Valencia, Spain; and. 5. Department of Pediatric, Emma Children's Hospital, Academic Medical Center-Amsterdam, VU University Medical Center, Amsterdam, Netherlands. 6. Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain; maximo.vento@uv.es.
Abstract
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.
RCT Entities:
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.
Authors: Vishal S Kapadia; Charitharth V Lal; Venkat Kakkilaya; Roy Heyne; Rashmin C Savani; Myra H Wyckoff Journal: J Pediatr Date: 2017-12 Impact factor: 4.406
Authors: Vishal Kapadia; Ju Lee Oei; Neil Finer; Wade Rich; Yacov Rabi; Ian M Wright; Denise Rook; Marijn J Vermeulen; William O Tarnow-Mordi; John P Smyth; Kei Lui; Steven Brown; Ola D Saugstad; Maximo Vento Journal: Resuscitation Date: 2021-08-20 Impact factor: 6.251
Authors: E Sabrina Twilhaar; Rebecca M Wade; Jorrit F de Kieviet; Johannes B van Goudoever; Ruurd M van Elburg; Jaap Oosterlaan Journal: JAMA Pediatr Date: 2018-04-01 Impact factor: 16.193
Authors: Kei Lui; Lisa J Jones; Jann P Foster; Peter G Davis; See Kwee Ching; Ju Lee Oei; David A Osborn Journal: Cochrane Database Syst Rev Date: 2018-05-04