RecruitingACTRN12620000065998

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

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


Sponsor

Gold Coast Health

Enrollment

60 participants

Start Date

Jan 29, 2020

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 35 WeekssMax Age: 5 Yearss

Plain Language Summary

Simplified for easier understanding

When young children get sick with respiratory infections, many are treated with high flow nasal cannula (HFNC) — a device that delivers warm, humidified oxygen through small prongs in the nose to help them breathe more easily. But here is an important safety question that has not been fully answered: is it safe for these children to eat and drink while on this support? This study investigates whether the increased pressure created by HFNC might interfere with a child's ability to swallow safely, potentially causing food or liquid to enter the lungs (called aspiration). A speech pathologist will assess the swallowing of 60 young children receiving HFNC using both bedside assessment tools and a specialised X-ray swallowing study. Children are grouped by age to compare risks across different developmental stages. This study is open to infants and children from 35 weeks corrected gestational age up to 5 years old who are receiving HFNC and are showing signs of readiness for oral feeding. Children with major chromosomal abnormalities, congenital conditions affecting swallowing, or severe neurological conditions are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 tr

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.


Locations(1)

Gold Coast University Hospital - Southport

QLD, Australia

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ACTRN12620000065998