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

NCT ID: NCT02124863

Last Updated: 2017-02-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-01-31

Brief Summary

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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

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Conditions

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Gastro-oesophageal Reflux

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intrapulmonary Percussive Ventilation

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

Group Type EXPERIMENTAL

Intrapulmonary Percussive Ventilation

Intervention Type DEVICE

20 min IPV freq 300/min, p 10cmH2O

Interventions

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Intrapulmonary Percussive Ventilation

20 min IPV freq 300/min, p 10cmH2O

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* infants from 0 to 12 months
* impedance monitoring

Exclusion Criteria

* gestational age \< 24w
* anti-reflux medication
* Nissen fundoplication
* no parental consent
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vrije Universiteit Brussel

OTHER

Sponsor Role lead

Responsible Party

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Filip Van Ginderdeuren

PT, Drs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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fili van ginderdeuren

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussel

Locations

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UZ Brussel

Jette, Brussels Capital, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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FVG002

Identifier Type: -

Identifier Source: org_study_id

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