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OpenTrials
Completed

NCT Number: NCT02128867

Safety Study of Airway Clearance Techniques in Infants.

The purpose of this study is to determine whether three airway clearance techniques ( Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate gastro-esophageal reflux in infants under the age of 1 year.

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Key information

Conditions

Gastro-esophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

1 day–365 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZBrussel

Jette, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • infants < 1 year
  • acid reflux monitoring

Exclusion criteria

  • gestational age <24 w
  • anti-reflux medication
  • Nissen fundoplication
  • no parental consent

Treatment and study plan

Assisted Autogenic Drainage (AAD)

Other

bouncing and AAD

Other

bouncing

Other

Primary outcomes

  1. Number of Refluxes

    Time frame: 15 minutes

    number of refluxes will be counted over a period of 15 minutes ( treatment time )

Secondary outcomes

  1. Duration of Reflux Episodes

    Time frame: 15 minutes

    duration of reflux episodes will be measured during 15 min of treatment time

Other outcomes

  1. Heartrate

    Time frame: 15 minutes

    heartrate will be measured during 15 min of treatment time

  2. Sa02

    Time frame: 15 minutes

    SaO2 will be measured during 15 minutes of treatment time

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

Influence of Bouncing, Assisted Autogenic Drainage (AAD) and Bouncing and AAD (BAAD) on Gastro-oesophageal Reflux ( GOR ), Oxygen Saturation (SaO2) and Heart Rate in Infants From 0 to 12 Months

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 1, 2014
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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