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

Gastro-oesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02124863
• Other study ID #: FVG002
• Status: Completed
• Phase: N/A
• First received: April 24, 2014
• Last updated: June 25, 2015
• Start date: September 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastro-oesophageal Reflux
• Gastroesophageal Reflux

Intervention

Device:
• Intrapulmonary Percussive Ventilation
20 min IPV freq 300/min, p 10cmH2O

Locations

Country	Name	City	State
Belgium	UZ Brussel	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 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.	No