High flow with Automatic Apnoeic oxygenation for Preterm Intubations - randomised controlled trial
Preterm intubations
All admitted neonates would be screened for study inclusion and exclusion criteria. For those infants who full fill the study criteria will be approached for prospective consent, whenever possible. When prospective consent not possible, recruited infants will be approached for retrospective consent. Once the decision has been made by the clinical team that a preterm infant needs placement of airway tube (TI), research team would assess the eligibility of the infant for study recruitment. If deemed eligible, Infant will be randomised 1:1 either to High flow with automated oxygen (HAAPI) or only high flow without automated oxygen HF group. Recruited infants in both groups would be placed on nasal high flow therapy of 7L/min at least 5 minutes before the procedure. We chose 7 L/min as this maximum flow rate used in our unit (unit practice). Target SpO2 for infants in both group will be 93% and oxygen (FiO2) in the HF group (standard group) would be under discretion of the attending clinical team and the infants in HAAPI group will be adjusted by the device. Infants in both groups would be connected to pulse oximetry sensor from the high flow device, which would enable us to collect continuous SpO2 and pulse rate data. Infants in both groups will also be connected to pulse oximeter sensor from the bedside monitors, which would allow the clinical team to monitor the vitals. High flow support in both groups will be continued until the procedure is completed. One of the member of the research team will collect the data contemporaneously. Study workbook provides all the data that will be collected for the study. Research team member blinded to the study randomisation and interventions will analyse the data related to primary and secondary outcomes.
1. Birth gestational age < 30 weeks based on mother’s last menstrual period or best obstetric estimate with first trimester ultrasound 2. Need for semi/elective intubation in the neonatal unit and the need ascertained by the neonatal team
Current exclusion criteria as of 15/09/2025: 1. Perceived difficult airway by the medical team. 2. Previous intubation episode with more than two intubation attempts for successful intubation by an experienced intubators (Neonatal Consultant). 3. Contraindication to High Flow Nasal Cannula (e.g., congenital nasal anomaly, congenital diaphragmatic hernia, or abdominal wall defect). 4. Delivery room intubations. 5. Emergency intubations as ascertained by the clinical team (e.g. Heart rate <100/min, apnea at the time of procedure). 6. LISA/MIST technique of surfactant administration 7. Infants diagnosed with pneumothorax needing needle or chest tube drainage. 8. Infants with cyanotic heart disease. _____ Previous exclusion criteria: 1. Perceived difficult airway by the medical team. 2. Previous intubation episode with more than two intubation attempts for successful intubation. 3. Delivery room intubations. 4. Emergency intubations as ascertained by the clinical team (e.g. Heart rate < 100/min, apnea at the time of procedure). 5. LISA/MIST technique of surfactant administration 6. Infants diagnosed with pneumothorax needing needle or chest tube drainage. 7. Infants with cyanotic heart disease.