Stabilisation with Nasal High Flow for Intubation of Neonates: The SHINE Trial

Not Applicable

Completed

• Conditions: Respiratory distress; Apnoea; Respiratory - Other respiratory disorders / diseases; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12618001498280
• Lead Sponsor: ewborn Research Centre, The Royal Women's Hospital, Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-06
• Study Completion: 2021-04-22
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

1.Any neonate undergoing endotracheal intubation in the delivery room or NICU AND
2.HR greater than or equal to 120bpm at the time of randomisation

Exclusion Criteria

1. Requirement for immediate endotracheal intubation as determined by the treating clinician, without time for randomisation and potential application of nHF, eg. active cardiopulmonary resuscitation
2. Heart rate <120 bpm at the time of randomisation
3. Contraindication to nHF use (eg. congenital nasal anomaly, congenital diaphragmatic hernia, abdominal wall defects)
4. Nasal intubation planned
5. Cyanotic congenital heart disease
6. Infant with proven or suspected COVID-19, or born to a mother with proven or suspected COVID-19.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the incidence of successful intubation at the first attempt without physiological instability. <br>‘Successful intubation’ is defined as the completion of the intubation attempt with correct positioning of the endotracheal tube confirmed by detection of expired carbon dioxide (CO2) on a colorimetric CO2 detector. <br>Beginning of ‘first attempt’ is defined as the first insertion of the laryngoscope beyond the infant’s lips. <br>End of 'first attempt' is defined as the removal of the laryngoscope from the baby’s mouth.<br>‘Physiological instability’ is defined as any desaturation to peripheral oxygen saturation >20% from baseline value or any bradycardia to a heart rate <100 beats per minute. ‘Baseline’ SpO2 will be recorded at the time at which the face mask is removed to commence intubation.<br>The difference in saturations is taken from the beginning of the intubation attempt, to the lowest saturations during the intubation attempt. [Completion of first intubation attempt ]