Initial supplementary oxygen concentration for moderate-late preterm infants receiving respiratory support in the delivery room: study protocol for the multicenter, cluster-randomized, crossover AIROPLANE trial.

BACKGROUND: Moderate-late preterm infants born at 32-35 completed weeks' gestation constitute a large proportion of all preterm births (< 37-week gestation), yet they are not well represented in the newborn resuscitation literature. Preterm infants often receive respiratory support in the delivery room, and recommendations exist to guide the use of supplemental oxygen when providing this support. However, there are minimal data regarding the best initial supplementary oxygen concentration for moderate-late preterm infants requiring respiratory support at birth, resulting in practice variation. The aim of this trial is to compare initial supplementary oxygen concentrations of 30% and 21% (air) in preterm infants of 32-35 weeks' gestation who require respiratory support in the delivery room, with a primary outcome of the need for ongoing respiratory support upon leaving the delivery room. METHODS: This is a prospective, unblinded, multicenter, cluster-randomized, crossover trial in Australian maternity hospitals comparing initial supplementary oxygen concentrations of 30% and 21% (air) in moderate-late preterm infants who require respiratory support at birth. Eligible infants are those born from 32 + 0 to 35 + 6 weeks' gestation without major cardiorespiratory or craniofacial anomalies, who are receiving active care, and who receive respiratory support in the delivery room within the first three minutes after birth. The primary outcome is the need for ongoing respiratory support upon leaving the delivery room. The trial will recruit a minimum of 1200 infants from at least 20 study sites in Australia using a waiver of consent process. DISCUSSION: The AIROPLANE trial is a pragmatic study in an underrepresented population using a novel study design. It will be the first randomized study of initial supplementary oxygen concentration during respiratory support in the delivery room to exclusively recruit moderate-late preterm infants. The results will address an important evidence gap and will inform future international guidelines. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12621001267842. Registered on 20th September 2021.