Influence of IPV on GOR in Infants From 0 to 12 Months.

Not Applicable

Completed

• Conditions: Gastro-oesophageal Reflux
• Interventions: Device: Intrapulmonary Percussive Ventilation

• Registration Number: NCT02124863
• Lead Sponsor: Vrije Universiteit Brussel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-25
• Study First Posted: 2014-04-28
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2015-02-23
• Results First Submitted QC: 2015-03-10
• Results First Posted: 2015-03-17
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-22
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• infants from 0 to 12 months
• impedance monitoring

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intrapulmonary Percussive Ventilation	Intrapulmonary Percussive Ventilation	number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding

Primary Outcome Measures

Name	Time	Method
Number of Refluxes	during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.	Every two hours after feeding, the number of refluxes during 20 minutes are measured. The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Brussels, Belgium