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Neurodevelopmental outcomes of preterm infants after randomisation to initial resuscitation with lower (FiO2 <0.3) or higher (FiO2 >0.6) initial oxygen levels. An individual patient meta-analysis

Abstract

Objective To determine the effects of lower (≤0.3) versus higher (≥0.6) initial fractional inspired oxygen (FiO2) for resuscitation on death and/or neurodevelopmental impairment (NDI) in infants <32 weeks’ gestation.

Design Meta-analysis of individual patient data from three randomised controlled trials.

Setting Neonatal intensive care units.

Patients 543 children <32 weeks’ gestation.

Intervention Randomisation at birth to resuscitation with lower (≤0.3) or higher (≥0.6) initial FiO2.

Outcome measures Primary: death and/or NDI at 2 years of age.

Secondary: post-hoc non-randomised observational analysis of death/NDI according to 5-minute oxygen saturation (SpO2) below or at/above 80%.

Results By 2 years of age, 46 of 543 (10%) children had died. Of the 497 survivors, 84 (17%) were lost to follow-up. Bayley Scale of Infant Development (third edition) assessments were conducted on 377 children. Initial FiO2 was not associated with difference in death and/or disability (difference (95% CI) −0.2%, −7% to 7%, p=0.96) or with cognitive scores <85 (2%, −5% to 9%, p=0.5). Five-minute SpO2 >80% was associated with decreased disability/death (14%, 7% to 21%) and cognitive scores >85 (10%, 3% to 18%, p=0.01). Multinomial regression analysis noted decreased death with 5-minute SpO2 ≥80% (odds (95% CI) 09.62, 0.98 to 0.96) and gestation (0.52, 0.41 to 0.65), relative to children without death or NDI.

Conclusion Initial FiO2 was not associated with difference in risk of disability/death at 2 years in infants <32 weeks’ gestation but CIs were wide. Substantial benefit or harm cannot be excluded. Larger randomised studies accounting for patient differences, for example, gestation and gender are urgently needed.

  • neonatology
  • resuscitation

Data availability statement

Data are available upon reasonable request. Data used in this study are under the ownership of the investigators of the original randomised controlled trials and were de-identified for analysis in this study.

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