Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001276145
Ethics application status
Approved
Date submitted
4/07/2019
Date registered
16/09/2019
Date last updated
24/02/2022
Date data sharing statement initially provided
16/09/2019
Date results information initially provided
15/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Cerebral oxygenation during neonatal intubation
Scientific title
Cerebral oxygenation during neonatal intubation: an observational study
Secondary ID [1] 298136 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a sub-study of ACTRN12618001498280.

Health condition
Health condition(s) or problem(s) studied:
Respiratory distress 312676 0
Cerebral blood flow 312677 0
Condition category
Condition code
Reproductive Health and Childbirth 311172 311172 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study of cerebral oxygenation using Near Infra Red Spectroscopy (NIRS) during neonatal intubation. This is a sub-study of the SHINE trial (ANZCTR 12618001498280) which is examining the use of nasal high flow therapy during neonatal intubation. This is an additional observational study at the Royal Women's Hospital, Melbourne, Australia, only. This sub-study will compare NIRS in those neonates receiving nasal high flow during intubation and those not receiving nasal high flow during intubation.
Intervention code [1] 314359 0
Not applicable
Comparator / control treatment
Observation of cerebral oxygenation (NIRS) will occur for a subset of patients in both arms of the SHINE trial (ANZCTR 12618001498280). The interventional arm of this trial has nasal high flow applied during intubation, and the control arm has no nasal high flow applied (standard care).
Control group
Active

Outcomes
Primary outcome [1] 319941 0
Mean difference from baseline of regional cerebral oxygen saturation (rScO2) between neonates receiving nasal high flow (nHF) during intubation compared with those not receiving nHF during intubation. The outcome is assessed using NIRS monitoring in both groups.
Timepoint [1] 319941 0
During first intubation attempt
Secondary outcome [1] 406772 0
Mean difference from baseline of fractional tissue oxygen extraction (FTOE) during the first intubation attempt between randomised groups. Assessed using Near Infra Red Spectroscopy (NIRS) and peripheral oxygen saturation monitoring.
Timepoint [1] 406772 0
During the first intubation attempt.
Secondary outcome [2] 406773 0
Mean rScO2 (%) during the first intubation attempt. Assessed using NIRS.
Timepoint [2] 406773 0
During the first intubation attempt
Secondary outcome [3] 406774 0
Absolute time (secs) that rScO2 is within 'normal' range (55-85%). Assessed using NIRS and video monitoring.
Timepoint [3] 406774 0
During the first intubation attempt
Secondary outcome [4] 406775 0
Absolute time (secs) that rScO2 is <55% (cerebral hypoxia). Assessed using NIRS.
Timepoint [4] 406775 0
During the first intubation attempt.
Secondary outcome [5] 406776 0
Absolute time (secs) that rScO2 is >85% (cerebral hyperoxia). Assessed using NIRS.
Timepoint [5] 406776 0
During the first intubation attempt.
Secondary outcome [6] 406777 0
Proportion of time (percentage) that rScO2 is within 'normal' range (55-85%). Assessed using NIRS.
Timepoint [6] 406777 0
During the first intubation attempt
Secondary outcome [7] 406778 0
Proportion of time (percentage) that rScO2 is <55% (cerebral hypoxia). Assessed using NIRS.
Timepoint [7] 406778 0
During the first intubation attempt
Secondary outcome [8] 406779 0
Proportion of time (percentage) that rScO2 is >85% (cerebral hyperoxia). Assessed using NIRS.
Timepoint [8] 406779 0
During the first intubation attempt
Secondary outcome [9] 406780 0
Mean cerebral FTOE during the first intubation attempt. Assessed using NIRS.
Timepoint [9] 406780 0
During the first intubation attempt
Secondary outcome [10] 406781 0
Rate of change of rScO2 for the first intubation attempt. Assessed using NIRS.
Timepoint [10] 406781 0
During the first intubation attempt

Eligibility
Key inclusion criteria
1. Any neonate undergoing endotracheal intubation in the delivery room or NICU AND
2. HR >120bpm at the time of randomisation
3. Prospective consent obtained from parent/guardian
4. Participation in the study ACTRN12618001498280
Minimum age
0 Days
Maximum age
6 Months
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

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Due to the paucity of available data regarding cerebral oxygen saturation during neonatal intubation, this will be an observational study without a formal sample size calculation. We aim to recruit a convenience sample of approximately 50 babies who are undergoing intubation in the NICU. This will enable a descriptive analysis of the effect of intubation on neonatal rScO2 as well as the difference between those infants receiving nHF and those in the control arm.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2019
Actual
13/09/2020
Date of last participant enrolment
Anticipated
1/11/2020
Actual
18/04/2021
Date of last data collection
Anticipated
6/11/2020
Actual
21/04/2021
Sample size
Target
50
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13683 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 26369 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 302664 0
Hospital
Name [1] 302664 0
Royal Women's Hospital
Country [1] 302664 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
Newborn Research Centre
Level 7, 20 Flemington Rd
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 302597 0
None
Name [1] 302597 0
Address [1] 302597 0
Country [1] 302597 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303287 0
Royal Women's Hospital
Ethics committee address [1] 303287 0
20 Flemington Rd
Parkville VIC 3052
Ethics committee country [1] 303287 0
Australia
Date submitted for ethics approval [1] 303287 0
02/08/2019
Approval date [1] 303287 0
20/08/2019
Ethics approval number [1] 303287 0

Summary
Brief summary
This is a sub-study of the SHINE randomised controlled trial (ACTRN12618001498280).

In this sub-study, we will also monitor oxygen supply to the brain (by placing a sensor on the forehead). We hope that this will give further information about the changes in oxygen delivery to the brain during placement of breathing tube for babies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93138 0
Dr Kate Hodgson
Address 93138 0
Newborn Research Centre,
Level 7, Newborn Research Centre
20 Flemington Rd
Parkville VIC 3052
Country 93138 0
Australia
Phone 93138 0
+61 0407567360
Fax 93138 0
Email 93138 0
[email protected]
Contact person for public queries
Name 93139 0
Dr Kate Hodgson
Address 93139 0
Newborn Research Centre,
Level 7, Newborn Research Centre
20 Flemington Rd
Parkville VIC 3052
Country 93139 0
Australia
Phone 93139 0
+61 3 83453763
Fax 93139 0
Email 93139 0
[email protected]
Contact person for scientific queries
Name 93140 0
Dr Kate Hodgson
Address 93140 0
Newborn Research Centre,
Level 7, Newborn Research Centre
20 Flemington Rd
Parkville VIC 3052
Country 93140 0
Australia
Phone 93140 0
+61 3 83453763
Fax 93140 0
Email 93140 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Cerebral oxygenation during neonatal intubation data (rSCO2) with or without high flow
When will data be available (start and end dates)?
After trial completion and paper publication, for 5 years.
Available to whom?
Researchers, upon reasonable request.
Available for what types of analyses?
Meta-analysis of data.
How or where can data be obtained?
Emailing PI- [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13204Study protocol  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCerebral Oxygenation during Neonatal Intubation with Nasal High Flow: A Sub-Study of the SHINE Randomized Trial.2023https://dx.doi.org/10.1159/000529870
N.B. These documents automatically identified may not have been verified by the study sponsor.