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

Vrije Universiteit Brussel

Status: Completed

Conditions: Gastro-oesophageal Reflux

Treatments: Device: Intrapulmonary Percussive Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT02124863

FVG002

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 1 day to 12 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• infants from 0 to 12 months
• impedance monitoring

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Intrapulmonary Percussive Ventilation

Experimental group

Description:

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

Treatment:

Device: Intrapulmonary Percussive Ventilation