OXY-PREEM-Trial
Does the use of 60% vs 30% oxygen reduce respiratory support in 32+0-35+6 week preterm infants?
Population
Preterm infants born at 32+0-35+6 weeks’ gestation
Primary Objective
Does resuscitation with 60% versus 30% initial oxygen reduce the need for respiratory support within the first hour after birth in moderate to late preterm infants (32+0-35+6 weeks’ gestation)?
Primary Hypothesis: Population (P), Intervention (I), Comparison (C), Outcome (O), Timeline (T):
P: In preterm infants born at 32+0-35+6 weeks’ gestation who require breathing support at delivery.
I: does initiating resuscitation with a higher oxygen concentration of 60%
C: compared to initiating with a lower oxygen concentration of 30%
O: increase or decrease the incidence of respiratory support
T: within the 1st hour after birth?
Design and Sample Size
This prospective cluster-crossover design, unmasked randomized controlled trial (RCT) comparing two oxygen concentrations at initiation of resuscitation. 1,520 - 760 control / 760 intervention
Inclusion Criteria
i) Infants with gestational age between 32+0-35+6 weeks based on best available obstetrical estimate, requiring respiratory support
ii) Infants designated to receive full resuscitation, i.e., no parental request or pre-determined decision to provide only comfort care at birth
iii) No known major congenital or chromosomal malformation.
Exclusion Criteria
i) Infant born outside of study centers and transported to centers after delivery.
Efficacy Endpoints
Primary:
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Respiratory support within the 1st hour after birth
Secondary:
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Delivery room interventions
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Admission temperature
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Neonatal UTSTEIN
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Mechanical ventilation
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Infection/sepsis
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Pneumothorax
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Brain injury as indicated by abnormal neuroimaging
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among others
Safety Evaluations
Adverse events
Statistical Methodology
Interim analyses will be conducted when 33% and 66% infants are participants complete primary outcome. The final analysis will be conducted after the study is completed, unblinded, and the database is released for analysis.
Clinical Centers
Canada
Enrolment Period: 3 years
ClinicalTrials.Gov Trial: