ActivePhase 3ACTRN12618000879268

Targeted Oxygenation in the Respiratory care of Premature Infants at Delivery: Effects on Outcome (TORPIDO 30/60)

Lower or higher initial oxygen concentration with Targeted Oxygen saturation in Respiratory care of premature Infants at Delivery: effects on Outcome (TORPIDO 30/60)

Sponsor

University of Sydney

Enrollment

1,470 participants

Start Date

Sep 13, 2018

Study Type

Interventional

Conditions

Premature infants requiring resuscitation at birth

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.

Eligibility

Sex: Both males and femalesMin Age: 23 WeekssMax Age: 29 Weekss

Inclusion Criteria1

Premature infants born from 23/0 to 28/6 weeks gestation

Exclusion Criteria1

Any known major cardiopulmonary abnormalities that could affect oxygenation or congenital malformations that could affect neuro-developmental outcome or survival

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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.