NCT02124863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
3 months until next milestone

Results Posted

Study results publicly available

March 17, 2015

Completed
Last Updated

February 10, 2017

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

April 24, 2014

Results QC Date

February 23, 2015

Last Update Submit

December 22, 2016

Conditions

Gastro-oesophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • Number of Refluxes

    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

    during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.

Study Arms (1)

Intrapulmonary Percussive Ventilation

EXPERIMENTAL

number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding

Device: Intrapulmonary Percussive Ventilation

Interventions

Intrapulmonary Percussive VentilationDEVICE

20 min IPV freq 300/min, p 10cmH2O

Intrapulmonary Percussive Ventilation

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • infants from 0 to 12 months
  • impedance monitoring

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
filip van ginderdeuren
Organization
vrije universiteit brussel
filip.vanginderdeuren@telenet.be
+3224763916

Study Officials

  • fili van ginderdeuren

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, Drs

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 28, 2014

Study Start

September 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 10, 2017

Results First Posted

March 17, 2015

Record last verified: 2016-12

Locations

BE(1)