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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001498280
Acronym
The SHINE trial
Enrollment
251
Registered
2018-09-06
Start date
2018-11-16
Completion date
2021-04-18
Last updated
2021-06-07

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

Conditions

None listed

Brief summary

The SHINE randomised controlled trial aims to compare the incidence of successful endotracheal intubation on the first attempt without physiological instability, between neonates receiving nasal high flow during intubation, and those receiving standard care. The primary outcome is the incidence of successful endotracheal intubation on the first attempt, without physiological instability, defined as absolute decrease in peripheral oxygen saturation >20% from baseline or heart rate <100 beats per minute during the first intubation attempt. We think that the use of high flow during intubation may increase the likelihood of the breathing tube being placed correctly on the first attempt, without the baby developing low blood oxygen levels or a low heart rate.

Interventions

All neonates being intubated in the delivery room or neonatal intensive care unit will be eligible for inclusion. Subsequent intubations in the same neonate will be eligible for inclusion if 1. The premedication/no premedication stratum differs OR 2. There is at least one week between intubations. Patients in the nasal High Flow (nHF) group will receive standard care up until the time of the continuous positive airways pressure (CPAP) face mask or prongs being removed for intubation. At this t

All neonates being intubated in the delivery room or neonatal intensive care unit will be eligible for inclusion. Subsequent intubations in the same neonate will be eligible for inclusion if 1. The premedication/no premedication stratum differs OR 2. There is at least one week between intubations. Patients in the nasal High Flow (nHF) group will receive standard care up until the time of the continuous positive airways pressure (CPAP) face mask or prongs being removed for intubation. At this time, nHF will be applied, with gas flow 8L/min and with FiO2 starting at the previous value. Nasal HF will be applied by one of the researchers. The aim is for babies in both groups to be stable prior to the randomisation and commencement of the intubation attempt. For non-urgent intubations it is expected that the oxygen saturations will generally be >90%. If the infant desaturates to <90%, the FiO2 will be increased to 1.0. In patients receiving premedications for intubation, nHF will be applied after the patient becomes apnoeic (i.e. medications will be administered, intermittent positive pressure ventilation (IPPV) will be provided if required, the CPAP face mask will be removed and then the nHF will be applied). Prongs will be secured underneath the patient’s head, but not with adhesive tape to the face. Nasal HF will continue during laryngoscopy, either until the first intubation attempt is successful, or abandoned and mask CPAP/IPPV is reinitiated, however long this may be. The intubation attempt will be abandoned at clinician discretion. At this time, nHF prongs will be removed. Nasal HF will not be reapplied for subsequent intubation attempts. IPPV will be provided using a standard bag-mask or T-piece (Neopuff), with the nHF prongs removed. Nasal HF will be administered using a portable Vapotherm Precision Flow device and binasal prongs. Only the first intubation attempt will be analysed for the primary and relevant secondary outcomes.

Sponsors

Newborn Research Centre, The Royal Women's Hospital, Melbourne
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026