None listed
Conditions
Brief summary
Premature infants usually need extra oxygen after birth because their lungs are not fully developed. However, their bodies do not yet have the ability to balance the stress that receiving that oxygen can cause. Oxygen is necessary for life, but both too much or too little can damage eyes, lungs, brain and other important organs of newborn babies. This study will compare outcomes of 1470 preterm infants up to 28/6 weeks gestation who have had respiratory care in the delivery room with (A) Initial FiO2 0.6 versus (B) Initial FiO2 0.3, followed by common SpO2 targeting until admission to NICU. FiO2, SpO2, and heart rate are recorded each minute from delivery of the child’s body for 10 minutes, then every 5 minutes until admission to NICU. Routine assessments are collected at baseline, 36 weeks, discharge and at 2 years corrected for gestation. Additionally a parent-completed developmental questionnaire is also collected at 2 years corrected for gestation.
Interventions
At delivery, a CPAP mask will be applied by the caregiver (e.g. midwife, neonatal clinician, obstetrician, anaesthetist), and initial FiO2 level will be set to 0.6. Using a pulse oximeter, FiO2 will be adjusted as required to achieve target SpO2 (80-85% at 5 min and 85-95% at 10 min and thereafter), until admission to the NICU.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
23 Weeks to 29 Weeks
Healthy volunteers
No
Inclusion criteria
Premature infants born from 23/0 to 28/6 weeks gestation
Exclusion criteria
Any known major cardiopulmonary abnormalities that could affect oxygenation or congenital malformations that could affect neuro-developmental outcome or survival
Outcome results
None listed