RecruitingPhase 1ACTRN12605000737639

TREATMENT OF PRIMARY ASPIRATION IN CHILDREN: A RANDOMISED CONTROLLED TRIAL TO DETERMINE EFFECTS OF UNLIMITED ORAL INTAKE OF WATER IN CHILDREN WITH DOCUMENTED ASPIRATION ON THIN FLUIDS.


Sponsor

Royal Children's Hospital

Enrollment

60 participants

Start Date

Mar 3, 2005

Study Type

Interventional

Conditions

Summary

Following detection of primary aspiration of thin fluids on MBS, participants are randomly assigned to a treatment group of restricted oral water intake (with thickened fluids) or unrestricted oral intake of water.


Eligibility

Sex: Both males and femalesMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for infants and children who have been found to be swallowing food or liquid into their lungs (called aspiration) during a special X-ray swallowing test. Aspiration can lead to lung problems. The study tests whether children who aspirate thin fluids (like water) do better if they are allowed to drink water freely, compared to children who are restricted to thickened fluids only. You may be eligible if: - You are an infant or child under 18 years old who is having a modified barium swallow study at the Royal Children's Hospital, Brisbane You may NOT be eligible if: - There are no specific exclusion criteria listed for this study Talk to your doctor about whether this trial might be right for you.

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

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Interventions

Unrestricted oral water intake (with thickened fluids)

Unrestricted oral water intake (with thickened fluids)


Locations(1)

Australia

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ACTRN12605000737639