Gastro-oesophageal RefluxNCT03346174
Influence of Airway Clearance Techniques on GOR in Infants
A study testing AAD and BAAD in people with Gastro-oesophageal Reflux, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 365 days
- Conditions the study is for
- Gastro-oesophageal Reflux
- What is being tested?
- AAD and BAAD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2019to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 365 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- prematurity (gestational age less than 37 weeks),
- the use of anti-reflux medication and reflux surgery (Nissen fundoplication)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Gastro-oesophageal Reflux
- Being tested
- AAD, BAAD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AADOther
In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of AAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ).
BAADOther
In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of BAAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ).
| Study group | Role | What they receive |
|---|---|---|
| AAD | Experimental | 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. Receives: Other: AAD |
| BAAD | Experimental | 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. Receives: Other: BAAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of refluxes
Measured: 20 minutes
Secondary outcomes (1)
number of acid refluxes
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Feb 2019
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-oesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Van Ginderdeuren, Vrije Universiteit Brussel
- Investigators
- Filip Van Ginderdeuren, PhD, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346174
- Sponsor's protocol ID
- FVG004
- Status last verified
- Dec 2020
- First submitted
- 9 Nov 2017
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03346174
- Acronym / sponsor ID
- FVG004
- Conditions
- Gastro-oesophageal Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AAD | Experimental | Other: AADAAD 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. |
| BAAD | Experimental | Other: BAADAAD 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. |
Who may qualify
- Ages
- 1 day to 365 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- prematurity (gestational age less than 37 weeks),
- the use of anti-reflux medication and reflux surgery (Nissen fundoplication)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AADIn this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of AAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ). | Other | AAD |
| BAADIn this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of BAAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ). | Other | BAAD |
Primary outcome
number of refluxes
Time frame: 20 minutes
1 secondary outcome
number of acid refluxes
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Van Ginderdeuren, PhD principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAD and BAAD in people with Gastro-oesophageal Reflux, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of refluxes (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.