OXY-ELGAN-Trial
Does the use of 100% vs 30% oxygen reduce incidence of emergency intubation in the delivery room in 21+0-25+6 week preterm infants?
Population
Preterm infants born at 21+0-25+6 weeks’ gestation
Primary Objective
Does resuscitation with 100% versus 30% initial oxygen reduce the incidence of emergency intubation in the delivery room in preterm infants (21+0-25+6 weeks’ gestation)?
Primary Hypothesis: Population (P), Intervention (I), Comparison (C), Outcome (O), Timeline (T):
P: In preterm infants born at 21+0-25+6 weeks’ gestation
I: does initiating resuscitation with a higher oxygen concentration of 100%
C: compared to initiating with a lower oxygen concentration of 30%
O: increase or decrease the incidence of emergency intubation in the delivery room
T: within the 1st 30 minutes after birth?
Design and Sample Size
This prospective unmasked randomized controlled trial (RCT) comparing two oxygen concentrations at initiation of resuscitation. 50 - 25 control / 25 intervention
Inclusion Criteria
i) Infants with gestational age between 21+0-25+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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incidence of emergency intubation in the delivery room within 30 minutes 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
The final analysis will be conducted after the study is completed, unblinded, and the database is released for analysis.
Clinical Center:
Royal Alexandra Hospital, Canada
Enrolment Period: 1 years
ClinicalTrials.Gov Trial: