ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000065998

Ethics application status

Approved

Date submitted

8/01/2020

Date registered

28/01/2020

Date last updated

25/02/2020

Date data sharing statement initially provided

28/01/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Oral Feeding and aspiration risk in children on high flow respiratory support.

Scientific title

Oral feeding safety and aspiration risk in infants and children receiving high flow nasal cannula respiratory support.

Secondary ID [1]

N/A

Universal Trial Number (UTN)

U1111-1246-1575

Trial acronym

Linked study record

N/A

Health condition

Health condition(s) or problem(s) studied:

oropharyngeal aspiration

high flow nasal cannula respiratory support

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Diet and Nutrition

Other diet and nutrition disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

All infants and children receiving HFNC greater than or equal to 2 Litres/kg/min will undergo a: i) Clinical feeding evaluation of swallowing with cervical auscultation and conducted by a dysphagia trained senior Speech Language Pathologist. Each child will have a small omnidirectional condenser microphone inserted into a fitted circular O-ring will be taped over the skin of the neck lateral to the cricoid cartilage to digitally record swallowing and breath sounds. The infant/child will ingest age appropriate fluids and/or foods and the feeding evaluation will be digitally video recorded. There will be no adjustment to the child's respiratory support during the feed. The infant/child's feeding performance and clinical signs suggestive of aspiration will be evaluated using a standardized data collection form, age appropriate rating scales including the Early Feeding Skills Assessment & Dysphagia Disorders Survey, and a checklist of 16 clinical signs suggestive of oropharyngeal aspiration.

ii) Within 24 hours, infants/children will undergo a videofluoroscopic swallow study with synchronized Cervical Auscultation (as described above). Infants will be positioned in a side-lying position for preterms, age appropriate feeding seat with tilt-in-space and postural supports for term infants and older children as appropriate. Infants/children will consume age appropriate fluids/foods mixed with water-soluble contrast (fluids) or barium sulphate powder (purees/semiosolids/solids). They will have no change to their respiratory support during the feed. Radiographic evidence of laryngeal penetration and/or aspiration will be scored according to the Penetration-aspiration scale.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Videofluoroscopic Swallow Study (VFSS) Oropharyngeal aspiration rating (as per the penetration-aspiration scale).

Timepoint [1]

At the time of VFSS Evaluation.

Secondary outcome [1]

Proportion of children with positive aspiration on VFSS predicted by Clinical Feeding Evaluation (CFE)

Timepoint [1]

At study completion.

Secondary outcome [2]

Proportion of children with positive aspiration on VFSS predicted by Clinical Feeding Evaluation + Cervical Auscultation (CFE+CA).

Timepoint [2]

At study completion

Secondary outcome [3]

Effect of flow rate on proportion of positive aspiration on VFSS; CFE & CFE+CA.

Timepoint [3]

At study completion

Eligibility

Key inclusion criteria

Eligible infants/children are those who are greater than or equal to 35 weeks corrected gestational age to 5 years on HFNC with minimum flow of greater than or equal to 2L/kg/min, indicate readiness cues for oral feeding, can manage oral secretions, are medically stable on their level of respiratory support, cleared by their physician for inclusion in the study and have parental consent.

Stratification: Children will be stratified into three groups: i) preterm to 1 month corrected age; ii) > 1 month corrected age to 1 year corrected age & iii) >1 year corrected age to 5 years.

Minimum age

35 Weeks

Maximum age

5 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria: Infants/children will be excluded if they have co-morbidities, such as major chromosomal or congenital anomalies or neurological (e.g. grade 3-4 hypoxic ischaemic encephalopathy, stroke, traumatic brain injury, severe intraventricular haemorrhage, periventricular haemorrhage, etc) disorders.

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Sample size & Data analysis: With N=60 (20 children in each age stratum), we will be able to determine the prevalence of aspiration to within ±7.5% overall, and to within ±10.0% in each of the three strata (assuming risk=10% and alpha=0.05).
(i) Aim 1: To determine the incidence of oropharyngeal aspiration detected by CFE, CFE+CA & VFSS during oral feeding in children receiving HFNC. This will report binary data on count & percentage n(%) for suspected aspiration: Yes/No (on CFE, CFE+CA & VFSS).
Aim (ii): To determine the association between flow rate and aspiration severity.

Main outcome variables: The relationship between VFSS aspiration score & flow rate will be analyses using logistic regression. Agreement between aspiration on CFE and CFE±CA compared to VFSS will be explored using sensitivity, specificity, positive and negative predictive values. Inter-rater reliability for acoustic and perceptual analysis of aspirating and non-aspirating swallow sounds will be determined using the kappa statistic (95% confidence intervals).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

29/01/2020

Actual

29/01/2020

Date of last participant enrolment

Anticipated

23/12/2020

Actual

Date of last data collection

Anticipated

24/12/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Gold Coast University Hospital - Southport

Recruitment postcode(s) [1]

4215 - Southport

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Gold Coast Health & Gold Coast Hospital Foundation Collaborative Grant

Address [1]

Gold Coast University Hospital, 1 Hospital Boulevard, Southport, Queensland, Australia.

Country [1]

Australia

Primary sponsor type

Hospital

Name

Gold Coast Health

Address

Gold Coast University Hospital, 1 Hospital Boulevard, Southport, 4215,Queensland, Australia.

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Griffith University

Address [1]

Gold Coast Campus, Parklands Drive, Southport, 4125 Queensland, Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Gold Coast Hospital & Health Service Human Research Ethics Committee (EC00160)

Ethics committee address [1]

Office for Research Governance & Development
Level 2, Pathology and Education Building
I Hospital Boulevard, Southport QLD 4215 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/04/2019

Approval date [1]

06/09/2019

Ethics approval number [1]

HREC/2019/QGC/53657

Summary

Brief summary

Respiratory illness is the most common reason for young children to be hospitalised. Many children receive High Flow Nasal Cannula (HFNC) respiratory support which delivers high flow rates of heated humidified air/oxygen to the nose through nasal prongs to assist their breathing. However, it is currently unknown whether it is safe for children to eat and drink whilst they are receiving HFNC support.  HFNC increases pharyngeal pressures to keep the airway open and reduce work of breathing, but it is suspected that these increased pressures may affect a child’s ability to protect their airway during swallowing. This may cause food or fluid into enter the child’s lungs when eating or drinking (oropharyngeal aspiration) when on HFNC, and this may damage the lungs and prolong the child’s recovery.

This study aims to determine whether oropharyngeal aspiration occurs (incidence of aspiration) by having a speech pathologist assess the child’s feeding and swallowing at the bedside (and listening to swallow sounds via a microphone attached to the throat) and whist eating and drinking during a videofluoroscopic swallow study (VFSS, a dynamic x-ray procedure). The research speech pathologist will assess 60 children from preterm (35 weeks gestational age) through to 5 years of age who are receiving HFNC respiratory support. We hypothesize that preterm and infant children will have a higher incidence of aspiration than older children; and that children on higher HFNC flow rates will have a higher incidence of aspiration than those on lower flow rates. Our study findings will inform the development of evidence-based guidelines to inform healthcare professionals about the safety for oral feeding of young children receiving HFNC respiratory support.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Kelly Weir

Address

C/ Speech Pathology Department, Griffith Health Centre, G40_2.69, Gold Coast Campus, Griffith University, Southport, Queensland 4222

Country

Australia

Phone

+61 7 5552 9595

Fax

kelly.weir@griffith.edu.au

Contact person for public queries

Name

Kelly Weir

Address

C/ Speech Pathology Department, Griffith Health Centre, G40_2.69, Gold Coast Campus, Griffith University, Southport, Queensland 4222

Country

Australia

Phone

+617 5552 9595

Fax

kelly.weir@griffith.edu.au

Contact person for scientific queries

Name

Kelly Weir

Address

C/ Speech Pathology Department, Griffith Health Centre, G40_2.69, Gold Coast Campus, Griffith University, Southport, Queensland 4222

Country

Australia

Phone

+61 7 5552 9595

Fax

kelly.weir@griffith.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Under conditions through which ethical approval was granted, data is only available to members of the research team.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6355	Informed consent form					379018-(Uploaded-08-01-2020-16-20-55)-Study-related document.pdf
6527	Study protocol			kelly.weir@griffith.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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