Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

ConditionsDysphagia Aspiration Brief Resolved Unexplained Event (BRUE)Apparent Life Threatening Event (ALTE)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeUp to 21

SponsorBoston Children's Hospital

About this trial

This study will examine the effects of varying liquid viscosity on swallow physiology in infants with oropharyngeal dysphagia and brief resolved unexplained event (BRUE) and other children with dysphagia that would be at risk for symptoms of swallow dysfunction.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 0 to 21 years

Admitted to Boston Children's Hospital after experiencing first lifetime BRUE, or with dysphagia symptoms such that they would be at risk for BRUE or other symptoms of swallowing difficulty

Have had videofluoroscopic swallow study performed or might have future videofluoroscopic swallow study performed.

Disqualifiers

Any pre-existing medical diagnoses that exclude brief resolved unexplained event diagnosis including seizure disorders and cyanotic congenital heart disease

Any nasal/pharyngeal/esophageal anomalies that might affect safe placement of the pharyngeal motility catheter

Children fed exclusively by enteral tube

Allergy to rice cereal or Gelmix thickener, which will be used to adjust liquid viscosity

Trial design

Design model

Crossover

Treatments tested in this trial

Thin liquid swallows
Dietary supplement
Thin liquid swallows of formula or breastmilk or other liquid
Slightly thickened liquid swallows
Dietary supplement
Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Mildly thickened liquid swallows
Dietary supplement
Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Moderately thickened liquid swallows
Dietary supplement
Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Treatment groups

200 Participants

are divided into 4 treatment groups

Group A: Thin liquid swallowsPlacebo comparator 1 intervention

Group B: Slightly thick liquid swallowsExperimental treatment 1 intervention

Group C: Mildly thick liquid swallowsExperimental treatment 1 intervention

Group D: Moderately thick liquid swallowsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Swallow risk indices for thin vs mildly thick vs slightly thick liquids

We will calculate swallow risk index (SRI) from impedance-manometry results to compare mean SRI with thin liquids and thickened liquids for subjects with aspiration compared to mean SRI for thin liquids and thickened liquids in subjects without aspiration.

Time frame

30 minutes

Secondary outcomes

Impedance-Manometry Swallow Physiology Metrics

We will measure swallow physiology metrics from impedance-manometry results, including post-swallow impedance ratio, to compare these parameters with thin liquids between subjects with and without aspiration and with varied liquid consistencies within subjects.

Time frame

30 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

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