ANZCTR - Registration

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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

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]

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

Cerebral blood flow

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

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]

During first intubation attempt

Secondary outcome [1]

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]

During the first intubation attempt.

Secondary outcome [2]

Mean rScO2 (%) during the first intubation attempt. Assessed using NIRS.

Timepoint [2]

During the first intubation attempt

Secondary outcome [3]

Absolute time (secs) that rScO2 is within 'normal' range (55-85%). Assessed using NIRS and video monitoring.

Timepoint [3]

During the first intubation attempt

Secondary outcome [4]

Absolute time (secs) that rScO2 is <55% (cerebral hypoxia). Assessed using NIRS.

Timepoint [4]

During the first intubation attempt.

Secondary outcome [5]

Absolute time (secs) that rScO2 is >85% (cerebral hyperoxia). Assessed using NIRS.

Timepoint [5]

During the first intubation attempt.

Secondary outcome [6]

Proportion of time (percentage) that rScO2 is within 'normal' range (55-85%). Assessed using NIRS.

Timepoint [6]

During the first intubation attempt

Secondary outcome [7]

Proportion of time (percentage) that rScO2 is <55% (cerebral hypoxia). Assessed using NIRS.

Timepoint [7]

During the first intubation attempt

Secondary outcome [8]

Proportion of time (percentage) that rScO2 is >85% (cerebral hyperoxia). Assessed using NIRS.

Timepoint [8]

During the first intubation attempt

Secondary outcome [9]

Mean cerebral FTOE during the first intubation attempt. Assessed using NIRS.

Timepoint [9]

During the first intubation attempt

Secondary outcome [10]

Rate of change of rScO2 for the first intubation attempt. Assessed using NIRS.

Timepoint [10]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Women's Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Women's Hospital

Address [1]

Newborn Research Centre
Level 7, 20 Flemington Rd
Parkville VIC 3052

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Women's Hospital

Ethics committee address [1]

20 Flemington Rd
Parkville VIC 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/08/2019

Approval date [1]

20/08/2019

Ethics approval number [1]

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

Dr Kate Hodgson

Address

Newborn Research Centre,
Level 7, Newborn Research Centre
20 Flemington Rd
Parkville VIC 3052

Country

Australia

Phone

+61 0407567360

Fax

[email protected]

Contact person for public queries

Name

Kate Hodgson

Address

Newborn Research Centre,
Level 7, Newborn Research Centre
20 Flemington Rd
Parkville VIC 3052

Country

Australia

Phone

+61 3 83453763

Fax

[email protected]

Contact person for scientific queries

Name

Kate Hodgson

Address

Newborn Research Centre,
Level 7, Newborn Research Centre
20 Flemington Rd
Parkville VIC 3052

Country

Australia

Phone

+61 3 83453763

Fax

[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.	Type	Citation	Link	Email	Other Details	Attachment
13204	Study protocol			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Cerebral Oxygenation during Neonatal Intubation with Nasal High Flow: A Sub-Study of the SHINE Randomized Trial.	2023	https://dx.doi.org/10.1159/000529870

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically