None listed
Conditions
Brief summary
Resair 3 is a phase 3 pragmatic multicentre, consent waiver, cluster randomised cross-over study of 51 hospitals in 9 countries that will recruit 481,774 term or near term infants (gestation >35 weeks) within 12 months to initial respiratory support with either air (21% O2) or pure (100% O2). O2 concentrations will be titrated according to preductal O2 saturations (SpO2) of healthy, full-term infants (1). The primary outcome is the need for advanced resuscitation interventions (one or more of the following: 1. Endotracheal intubation/supraglottic airway 2. Cardiac compressions 3. Adrenaline) and death before hospital discharge. Resair 3 will use interventions and data collection methods that are part of routine care. The hypothesis is that initiating resuscitation of term/near term infants with 100% oxygen and then titrating according to clinical condition and oxygen saturations will lead to reduction in the need for advanced resuscitation interventions and death before hospital discharge, compared to initiating resuscitation with 21% oxygen and then titrating upwards.
Interventions
The intervention: 100% oxygen will be administered by mask/nasal prongs/endotracheal tube/laryngeal airway or whatever modality that is used for best respiratory support for the newborn infant. FiO2 will be decreased/increased according to pre ductal SpO2. The intervention will be administered by the clinician attending the birth (doctor, nurse, respiratory technician). The intervention will be monitored by 1) clinical signs (e.g. heart rate, infant breathing response and colour) and 2) pulse ox
The intervention: 100% oxygen will be administered by mask/nasal prongs/endotracheal tube/laryngeal airway or whatever modality that is used for best respiratory support for the newborn infant. FiO2 will be decreased/increased according to pre ductal SpO2. The intervention will be administered by the clinician attending the birth (doctor, nurse, respiratory technician). The intervention will be monitored by 1) clinical signs (e.g. heart rate, infant breathing response and colour) and 2) pulse oximetry and if available 3) ECG. The duration for washout between interventions is 1 month. Prespecified gestation categories are greater or equal to 35 weeks gestation i.e. 35+ 0 weeks gestation and above
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Infants with a gestational age of 35+0 and above weeks by best obstetric estimate (1st trimester dating scan, maternal dates or estimation of fetal weight) will be included if there is 1) no previous request or predetermined decision to provide only comfort care at birth 2) no known congenital problem affecting oxygenation 3) no known major congenital abnormality that will impact survival
Exclusion criteria
Infants who are born outside of study hospitals and transported to hospitals after delivery, who are designated for comfort care only, or have congenital problems affecting oxygenation and survival will be excluded
Outcome results
None listed