Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001498280
Ethics application status
Approved
Date submitted
3/09/2018
Date registered
6/09/2018
Date last updated
31/05/2021
Date data sharing statement initially provided
9/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Stabilisation with Nasal High Flow for Intubation of Neonates: The SHINE Trial
Scientific title
Stabilisation with Nasal High Flow for Intubation of Neonates: The SHINE Trial.
Secondary ID [1] 295920 0
None
Universal Trial Number (UTN)
Trial acronym
The SHINE trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory distress 309406 0
Apnoea 309407 0
Condition category
Condition code
Respiratory 308259 308259 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 308260 308260 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312242 0
Treatment: Devices
Comparator / control treatment
Patients in the control arm will receive standard care. Mask CPAP will be removed for laryngoscopy. Only the first intubation attempt will be analysed for the primary and secondary outcomes. Intubation will occur in accordance with Royal Women's Hospital or Monash Newborn guidelines; no nHF will be applied during the intubation.
Control group
Active

Outcomes
Primary outcome [1] 307228 0
The primary outcome is the incidence of successful intubation at the first attempt without physiological instability.
‘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.
Beginning of ‘first attempt’ is defined as the first insertion of the laryngoscope beyond the infant’s lips.
End of 'first attempt' is defined as the removal of the laryngoscope from the baby’s mouth.
‘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.
The difference in saturations is taken from the beginning of the intubation attempt, to the lowest saturations during the intubation attempt.
Timepoint [1] 307228 0
Completion of first intubation attempt
Secondary outcome [1] 351192 0
Incidence of successful intubation on the first attempt (regardless of physiological stability), determined by colour change on colorimetric CO2 detector
Timepoint [1] 351192 0
First intubation attempt
Secondary outcome [2] 351460 0
Incidence of desaturation (absolute decrease in SpO2 >20% from baseline), determined using Masimo downloadable oximetry
Timepoint [2] 351460 0
First intubation attempt
Secondary outcome [3] 351461 0
Time to desaturation (absolute decrease in SpO2 >20% from baseline) during first intubation attempt in seconds. Time zero is defined as the time the laryngoscope is inserted past the infant’s lips
Timepoint [3] 351461 0
First intubation attempt
Secondary outcome [4] 351462 0
Duration of desaturation (absolute decrease in SpO2 >20% from baseline) during first intubation attempt, determined by Masimo downloadable oximetry, in seconds
Timepoint [4] 351462 0
First intubation attempt
Secondary outcome [5] 351463 0
Number of intubation attempts, defined as the number of times the laryngoscope is inserted beyond the infant’s lips, determined by direct observation by the researcher and verified with video recording
Timepoint [5] 351463 0
This intubation episode (all attempts)
Secondary outcome [6] 351464 0
Duration of all attempts (successful and unsuccessful), using video recording time stamps.
Timepoint [6] 351464 0
This intubation episode (all attempts)
Secondary outcome [7] 351465 0
Incidence of cardiac compressions and/or adrenaline administration within one hour after first intubation attempt, determined by direct observation by the researcher and verified with medical records.
Timepoint [7] 351465 0
Within 1 hour after first intubation attempt.
Secondary outcome [8] 351466 0
Incidence of pneumothorax within 72 hours after randomisation, diagnosed either by transillumination of the chest and/or by chest X-ray. Screening will be performed of medical records and electronic x-ray systems.
Timepoint [8] 351466 0
72 hours after randomisation
Secondary outcome [9] 351467 0
Incidence of pneumothorax requiring drainage (via needle thoracocentesis or insertion of an intercostal catheter) within 72 hours after randomisation. Screening via medical records and electronic imaging system.
Timepoint [9] 351467 0
72 hours after randomisation
Secondary outcome [10] 351468 0
Death within 72 hours after randomisation, determined by database screening, follow up and medical records.
Timepoint [10] 351468 0
72 hours after randomisation
Secondary outcome [11] 351528 0
Incidence of bradycardia (HR<100bpm), determined by downloadable Masimo oximetry
Timepoint [11] 351528 0
First intubation attempt
Secondary outcome [12] 351529 0
Duration of bradycardia (HR<100bpm), determined by downloadable Masimo oximetry, in seconds.
Timepoint [12] 351529 0
First intubation attempt
Secondary outcome [13] 351530 0
Time to bradycardia (HR<100bpm) in seconds. Time zero is when the laryngoscope touches the infants lips. Determined by downloadable Masimo oximetry.
Timepoint [13] 351530 0
First intubation attempt.
Secondary outcome [14] 396302 0
Median SpO2 during first intubation attempt. Assessed by pulse oximetry, averaging time 2 seconds.
Timepoint [14] 396302 0
First intubation attempt
Secondary outcome [15] 396303 0
Median heart rate (beats per minute) during first intubation attempt. Assessed using pulse oximetry, averaging time 2 seconds.
Timepoint [15] 396303 0
First intubation attempt
Secondary outcome [16] 396304 0
Duration of SpO2 >97% during first intubation attempt, in seconds. Assessed using pulse oximetry, averaging time 2 seconds.
Timepoint [16] 396304 0
First intubation attempt

Eligibility
Key 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
Minimum age
0 Days
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed. Will be performed by a central block randomisation (electronic) with the REDCap randomisation tool.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2018
Actual
16/11/2018
Date of last participant enrolment
Anticipated
1/04/2020
Actual
18/04/2021
Date of last data collection
Anticipated
Actual
22/04/2021
Sample size
Target
246
Accrual to date
Final
251
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11742 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 11743 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 23824 0
3052 - Parkville
Recruitment postcode(s) [2] 23825 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 300517 0
Hospital
Name [1] 300517 0
The Royal Women's Hospital
Country [1] 300517 0
Australia
Funding source category [2] 300518 0
Government body
Name [2] 300518 0
National Health and Medical Research Council
Country [2] 300518 0
Australia
Funding source category [3] 300579 0
Commercial sector/Industry
Name [3] 300579 0
Vapotherm Inc (Exeter, NH)
Country [3] 300579 0
United States of America
Primary sponsor type
Hospital
Name
Newborn Research Centre, The Royal Women's Hospital, Melbourne
Address
20 Flemington Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 299992 0
None
Name [1] 299992 0
Address [1] 299992 0
Country [1] 299992 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301307 0
Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 301307 0
Ethics committee country [1] 301307 0
Australia
Date submitted for ethics approval [1] 301307 0
05/09/2018
Approval date [1] 301307 0
08/11/2018
Ethics approval number [1] 301307 0
Ethics committee name [2] 308652 0
Monash Health Human Research Ethics Committee
Ethics committee address [2] 308652 0
Ethics committee country [2] 308652 0
Australia
Date submitted for ethics approval [2] 308652 0
16/01/2019
Approval date [2] 308652 0
01/03/2019
Ethics approval number [2] 308652 0
NMA HREC Reference Number: HREC/49330/MonH-2019-162591(v1) Project ID Code: 49330 Monash Health Ref: RES-19-0000034A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86578 0
Dr Kate Hodgson
Address 86578 0
Newborn Research Centre, 20 Flemington Rd, Parkville VIC 3052
Country 86578 0
Australia
Phone 86578 0
+61407567360
Fax 86578 0
Email 86578 0
[email protected]
Contact person for public queries
Name 86579 0
Kate Hodgson
Address 86579 0
Newborn Research Centre, 20 Flemington Rd, Parkville VIC 3052
Country 86579 0
Australia
Phone 86579 0
+61407567360
Fax 86579 0
Email 86579 0
[email protected]
Contact person for scientific queries
Name 86580 0
Kate Hodgson
Address 86580 0
Newborn Research Centre, 20 Flemington Rd, Parkville VIC 3052
Country 86580 0
Australia
Phone 86580 0
+61407567360
Fax 86580 0
Email 86580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation (the SHINE trial): A study protocol.2020https://dx.doi.org/10.1136/bmjopen-2020-039230
EmbaseNasal High-Flow Therapy during Neonatal Endotracheal Intubation.2022https://dx.doi.org/10.1056/NEJMoa2116735
N.B. These documents automatically identified may not have been verified by the study sponsor.