Initial Oxygen Concentration at Birth in Late-Preterm Infants
ConditionPreterm Birth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-10
SponsorUniversity of Alberta
About this trial
This study is aims to examine the best amount of oxygen to give preterm babies (born between 32 and 35 weeks) right after birth.
In the past, doctors used high levels of oxygen, but research has shown that using lower levels might help reduce the risk of death in full-term babies without harming brain development. However, investigators don't know the best oxygen level for babies born a little early (32 to 35 weeks). Some early data suggests that giving lower oxygen levels (FiO2 0.3) may not help babies reach healthy oxygen levels by 5 minutes after birth. This study will compare two oxygen levels-FiO2 0.6 and FiO2 0.3 to see which helps babies breathe better and need less ongoing breathing support. Researchers will study over 1,500 babies in hospitals across Alberta, Canada, to find the safest approach for these babies.
Eligibility criteria
Qualifiers
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.
Disqualifiers
i) Infant born outside of study centers and transported to centers after delivery.
Trial design
Treatments tested in this trial
- 60% Oxygen Group - Infants will start in 60% oxygen
- 30% Oxygen Group - Infants will start in 30% oxygen
Treatment groups
1,520 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov