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OpenTrials
Completed

NCT Number: NCT02124863

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

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.

Completed

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Key information

Conditions

Gastro-oesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • infants from 0 to 12 months
  • impedance monitoring

Exclusion criteria

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

Treatment and study plan

intrapulmonary percussive ventilation

Device

20 min IPV freq 300/min, p 10cmH2O

Primary outcomes

  1. Number of Refluxes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR) in Infants From 0 to 12 Months.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2014
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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