N/A
N=159
Safety Study of Airway Clearance Techniques in Infants.
Gastro-esophageal Reflux
Bottom Line
View on ClinicalTrials.gov: NCT02128867 ↗Enrolled (actual)
159
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Number of Refluxes — 0.48; 1.14; 1.62 number of refluxes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Assisted Autogenic Drainage (AAD) (Other); bouncing and AAD (Other); bouncing (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Vrije Universiteit Brussel
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Refluxes |
0.48; 1.14; 1.62 | — |
| SECONDARY Duration of Reflux Episodes |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- infants < 1 year
- acid reflux monitoring
Exclusion Criteria
- gestational age <24 w
- anti-reflux medication
- Nissen fundoplication
- no parental consent
Data sourced from ClinicalTrials.gov (NCT02128867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.