N/A
N=67
Influence of IPV on GOR in Infants From 0 to 12 Months.
Gastro-oesophageal Reflux
Bottom Line
View on ClinicalTrials.gov: NCT02124863 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Number of Refluxes — 0.48; 0.97 number of refluxes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intrapulmonary Percussive Ventilation (Device)
- 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; 0.97 | — |
Summary
The purpose of this study is to determine whether Intrapulmonary Percussive Ventilation ( airway clearance technique) provokes or aggravates gastro-oesophageal reflux in infants from 0 to 12 months.
Eligibility Criteria
Inclusion Criteria
- infants from 0 to 12 months
- impedance monitoring
Exclusion Criteria
- gestational age < 24w
- anti-reflux medication
- Nissen fundoplication
- no parental consent
Data sourced from ClinicalTrials.gov (NCT02124863). 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.