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Influence of Airway Clearance Techniques on GOR in Infants

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ClinicalTrials.gov Identifier: NCT03346174
Recruitment Status : Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether Assisted Autogenic Drainage (AAD) or bouncing combined with Assisted Autogenic Drainage (BAAD), induces or aggravates acid and non-acid gastro-oesophageal reflux in infants under the age of one year. Infants, referred to the hospital for impedance-pH monitoring are included in this study.

Condition or disease Intervention/treatment
Gastro-oesophageal Reflux Other: AAD Other: BAAD

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Data will be analyzed by an experienced paediatric gastro-enterologist, blinded to the different treatment modalities
Primary Purpose: Treatment
Official Title: Influence of Assisted Autogenic Drainage (AAD) and Bouncing Combined With Assisted Autogenic Drainage (BAAD) on Acid and Non-acid Gastro-oesophageal Reflux (GOR) in Infants < 1 Year
Anticipated Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: AAD
AAD is an airway clearance technique for infants based upon the principles of autogenic drainage. By modulating manually the functional breathing level within the vital capacity, optimal airflow will be obtained at the targeted airway generations, where secretions have been identified. A gentle increase of manual pressure on the chest during each inspiration is performed to guide the breathing of the patient towards the desired lung volume level. During expiration the breathing movement of the patient is followed gently.
Other: AAD
Infants will be treated with AAD for 20 minutes. Number of refluxes will be analyzed over this treatment period. These results will be compared with the results of the control group.
Experimental: BAAD
AAD is an airway clearance technique for infants based upon the principles of autogenic drainage .AAD sometimes leads to crying or resistance against therapy.Bouncing (at low amplitude:6-8 cm) in a stable upright position is a gentle up-and-down movement on a physio ball. It is not an ACT, but used to maximize the relaxation of the infant, avoiding resistance against or crying during treatment. Due to the relaxing effect of bouncing, infants appear to tolerate better AAD, increasing the effectiveness of the treatment.
Other: BAAD
Infants will be treated with bouncing combined with AAD (BAAD) for 20 minutes. Number of refluxes will be analyzed over this treatment period. These results will be compared with the results of the control group.
No Intervention: control group
Infants were kept in a stable upright position.


Outcome Measures

Primary Outcome Measures :
  1. number of refluxes [ Time Frame: 20 minutes ]

Secondary Outcome Measures :
  1. number of acid refluxes [ Time Frame: 20 minutes ]

Other Outcome Measures:
  1. number of non-acid refluxes [ Time Frame: 20 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 365 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Each child under the age of 1 year, referred for 24 h impedance monitoring to confirm a clinically suspected diagnosis of pathological GOR will be included

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346174


Contacts
Contact: filip van ginderdeuren, PhD +3224763916 filip.vanginderdeuren@uzbrussel.be
Contact: Marie-Laure Sibret, MsC +32487463689 msibret@vub.be

Sponsors and Collaborators
Vrije Universiteit Brussel
Investigators
Principal Investigator: Filip Van Ginderdeuren, PhD Vrije Universiteit Brussel
More Information

Responsible Party: Filip Van Ginderdeuren, Prof. Dr., Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT03346174     History of Changes
Other Study ID Numbers: FVG004
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases