Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR).

Gastro-oesophageal Reflux Clinical Trial

Official title:

Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR) in Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620241
• Other study ID #: VrijeUB
• Status: Completed
• Phase: N/A
• First received: November 30, 2015
• Last updated: November 6, 2017
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluates the effect on gastro-oesophageal reflux (GOR) of infants sitting in a stable upright position during 20 min. This is an addendum to the previous study with record number clinical trials.gov NCT02124863

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 365 Days

Eligibility

Inclusion Criteria:

• Each child under the age of one year that was referred for 24h pH-MII monitoring to exclude pathological gastro-oesophageal reflux (GOR)

Exclusion Criteria:

• : prematurity (gestational age less than 37 weeks), the use of anti-reflux medication and reflux surgery (Nissen fundoplication)

Related Conditions & MeSH terms

• Gastro-oesophageal Reflux
• Gastroesophageal Reflux

Intervention

Other:
• sitting position

Locations

Country	Name	City	State
Belgium	UZBrussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of reflux episodes	number of reflux episodes is counted over 20 min period of time	20 minutes