None listed
Conditions
Brief summary
Oxygen is necessary for life, but both too much or too little, can damage eyes, lungs and brain. The preterm infant is unique, while their ability to cope with too much oxygen (oxidative stress) is limited, they also need some oxygen after birth because their lungs are not fully developed. The Torpido2 Study aims to show that preterm infants born at less than 28 completed weeks gestation who have had delivery room resuscitation initiated with 21% (air) followed by lower oxygen targeting until admission to NICU will have improved outcomes when compared with similar infants who have had delivery room resuscitation initiated with 60% oxygen followed by higher oxygen targeting until admission to NICU.
Interventions
Randomised infants are placed on the resuscitation bed and initial care is per local protocol. Adequate lung expansion is achieved with CPAP or ventilation. A pulse oximeter sensor is placed on the right wrist and connected to the Masimo pulse oximeter. Initial FiO2 is set to 0.21. Once oximetry readings are established, FiO2 is adjusted every 30 seconds to achieve target SpO2 values of 80% at 5 minutes and 90% at 10 minutes and after. This is a one off intervention that will last about 20-30 mi
Randomised infants are placed on the resuscitation bed and initial care is per local protocol. Adequate lung expansion is achieved with CPAP or ventilation. A pulse oximeter sensor is placed on the right wrist and connected to the Masimo pulse oximeter. Initial FiO2 is set to 0.21. Once oximetry readings are established, FiO2 is adjusted every 30 seconds to achieve target SpO2 values of 80% at 5 minutes and 90% at 10 minutes and after. This is a one off intervention that will last about 20-30 minutes (average duration of respiratory care in the delivery room). Infants may be given pure oxygen (FiO2 1.0) if 1. The infant's heart rate falls below 100 bpm despite adequate ventilation, 2. SpO2 is less than 65% at or after 5 minutes, and/or 3. external cardiac massage or resuscitation medications are required at any time. Management after the infant leaves the delivery room will be as per institutional guidelines.
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 28 Weeks
Healthy volunteers
No
Inclusion criteria
Birth at 23 weeks to 28 weeks 6 days gestation Signed, written informed consent by parent(s) or legal guardian
Exclusion criteria
Delivery outside study centre Any major cardiopulmonary abnormalities that could affect oxygenation or congenital malformations that could affect neuro-developmental outcome Anticipated inability to follow-up at 2 years
Outcome results
None listed