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Automatic high flow oxygen support for tiny babies during breathing tube placement – a research study

High flow with Automatic Apnoeic oxygenation for Preterm Intubations - randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40770512
Enrollment
60
Registered
2025-04-07
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm intubations Pregnancy and Childbirth

Interventions

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. Wh

Sponsors

South Tees Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0 Weeks to 30 Weeks

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Time to oxygen desaturate defined as drop in oxygen saturation (Spo2) by 20% from baseline for duration of the intubation attempt

Secondary

MeasureTime frame
1. Total number of intubation attempts before successfully placing the breathing tube 2. Severity of desaturation: Change in baseline oxygen saturation prior to the intubation procedure to lowest Spo2 value during the intubation procedure measured using continuous pulse oximetry 3. Lowest and highest oxygen saturation (Spo2) during the procedure measured using continuous pulse oximetry 4. Proportion of time Spo2 within the target range 90-95% measured using continuous pulse oximetry 5. Proportion of time Spo2 above 95% measured using continuous pulse oximetry 6. Proportion of time oxygen saturation below 80%: Time below Spo2 80%/ Total duration of intubation procedure measured using continuous pulse oximetry

Countries

England, United Kingdom

Contacts

Public ContactPrakash Kannan Loganathan
pkannanloganathan@nhs.net+44 1642 854874

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 22, 2026