The Torpido2 Study: Targeted Oxygenation in the Respiratory care of Premature Infants at Delivery: Effects on developmental Outcome

INTERVENTION: 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. CONDITION: Bronchopulmonary dysplasia in premature infants Extreme prematurity Mortality in premature infants Oxidative stress in premature infants Resuscitation of premature infants Retinopathy in premature infants PRIMARY OUTCOME: Survival without major disability. Major disability is defined by 1. A score below the cut‐off indicative of developmental delay on the Ages and Stages Questionnaire (ASQ), 2. Moderate or severe cognitive deficit defined as less than or equal to 80 as assessed by the Bayley Scales of Infant Development III (BSIDIII), or 3. if ASQ or BSIDIII is unavailable, assessment by a medically qualified practitioner documenting at least one of the following: major developmental delay, including language or speech problems; or cerebral palsy with inability to walk unassisted at or after 2 years corrected age; or severe visual loss (cannot fixate/legally blind, or corrected acuity less than 6/60 in both eyes); or deafness requiring a hearing aid or cochlear implant SECONDARY OUTCOME: All‐cause mortality Brain Injury defined as grade 3 or 4 intraventricular haemorrhage (on either side of the head) seen on ultrasound according to the system of grading defined by the Australian and New Zealand Neonatal Network (ANZNN) guidelines, or presence by ultrasound of any of the following: periventricular leukomalacia (PVL), porencephalic cysts or hydrocephalus requiring neurosurgical intervention. Duration of hospital stay assessed by review of medical records. Head circumference measured in centimetres as per each individual hospital's protocol. In hospital survival without Bronchopulmonary Dysplasia (BPD) In‐hospital survival without severe Retinopathy of Prematurity (ROP) Late onset sepsis assessed by review of medical records. Necrotising enterocolitis receiving surgery or causing death Patent Ductus Arteriosus (PDA) requiring treatment Respiratory morbidity and complications measured as quantitative comparisons of total duration and type of respiratory support as well as occurrence of any of the following: pulmonary hypertension, pulmonary haemorrhage or pneumothorax. This will be assessed by review of medical records. Spontaneous Intestinal Perforation defined as the infant sustaining an intestinal perforation that is not associated with NEC nor with any bowel abnormality (ex: obstruction, atresia) nor with any mechanical trauma (e.g nasogastric tube). This will be assessed by review of medical records. Weight measured in grams as per each individual hospital's protocol at 36 weeks INCLUSION CRITERIA: Birth at 23 weeks to 28 weeks 6 days gestation Signed, written informed consent by parent(s) or legal guardian