Trial Review

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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] 300208 0
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 315764 0
high flow nasal cannula respiratory support 315765 0
Condition category
Condition code
Respiratory 314048 314048 0 0
Other respiratory disorders / diseases
Diet and Nutrition 314049 314049 0 0
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] 316481 0
Diagnosis / Prognosis
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322449 0
Videofluoroscopic Swallow Study (VFSS) Oropharyngeal aspiration rating (as per the penetration-aspiration scale).
Timepoint [1] 322449 0
At the time of VFSS Evaluation.
Secondary outcome [1] 378579 0
Proportion of children with positive aspiration on VFSS predicted by Clinical Feeding Evaluation (CFE)
Timepoint [1] 378579 0
At study completion.
Secondary outcome [2] 379009 0
Proportion of children with positive aspiration on VFSS predicted by Clinical Feeding Evaluation + Cervical Auscultation (CFE+CA).
Timepoint [2] 379009 0
At study completion
Secondary outcome [3] 379010 0
Effect of flow rate on proportion of positive aspiration on VFSS; CFE & CFE+CA.
Timepoint [3] 379010 0
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?
No
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
60
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15583 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 28970 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 304639 0
Hospital
Name [1] 304639 0
Gold Coast Health & Gold Coast Hospital Foundation Collaborative Grant
Country [1] 304639 0
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] 304937 0
University
Name [1] 304937 0
Griffith University
Address [1] 304937 0
Gold Coast Campus, Parklands Drive, Southport, 4125 Queensland, Australia
Country [1] 304937 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305059 0
Gold Coast Hospital & Health Service Human Research Ethics Committee (EC00160)
Ethics committee address [1] 305059 0
Office for Research Governance & Development
Level 2, Pathology and Education Building
I Hospital Boulevard, Southport QLD 4215 Australia
Ethics committee country [1] 305059 0
Australia
Date submitted for ethics approval [1] 305059 0
17/04/2019
Approval date [1] 305059 0
06/09/2019
Ethics approval number [1] 305059 0
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 99130 0
Dr Kelly Weir
Address 99130 0
C/ Speech Pathology Department, Griffith Health Centre, G40_2.69, Gold Coast Campus, Griffith University, Southport, Queensland 4222
Country 99130 0
Australia
Phone 99130 0
+61 7 5552 9595
Fax 99130 0
Email 99130 0
[email protected]
Contact person for public queries
Name 99131 0
Dr Kelly Weir
Address 99131 0
C/ Speech Pathology Department, Griffith Health Centre, G40_2.69, Gold Coast Campus, Griffith University, Southport, Queensland 4222
Country 99131 0
Australia
Phone 99131 0
+617 5552 9595
Fax 99131 0
Email 99131 0
[email protected]
Contact person for scientific queries
Name 99132 0
Dr Kelly Weir
Address 99132 0
C/ Speech Pathology Department, Griffith Health Centre, G40_2.69, Gold Coast Campus, Griffith University, Southport, Queensland 4222
Country 99132 0
Australia
Phone 99132 0
+61 7 5552 9595
Fax 99132 0
Email 99132 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
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.TypeCitationLinkEmailOther DetailsAttachment
6355Informed consent form    379018-(Uploaded-08-01-2020-16-20-55)-Study-related document.pdf
6527Study protocol  [email protected]



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.