Gastro-esophageal RefluxNCT02128867
Safety Study of Airway Clearance Techniques in Infants.
A study testing Assisted Autogenic Drainage (AAD), bouncing and AAD and bouncing in people with Gastro-esophageal Reflux, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The purpose of this study is to determine whether three airway clearance techniques ( Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate gastro-esophageal reflux in infants under the age of 1 year. Read more about this study
- Who is it for?
- Ages 1 day to 365 daysHealthy volunteers can take part
- Conditions the study is for
- Gastro-esophageal Reflux
- What is being tested?
- Assisted Autogenic Drainage (AAD), bouncing and AAD and bouncing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child
Who may be able to join
- infants < 1 year
- acid reflux monitoring
Who cannot join
- gestational age <24 w
- anti-reflux medication
- Nissen fundoplication
- no parental consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Bouncing, Assisted Autogenic Drainage (AAD) and Bouncing and AAD (BAAD) on Gastro-oesophageal Reflux ( GOR ), Oxygen Saturation (SaO2) and Heart Rate in Infants From 0 to 12 Months
The purpose of this study is to determine whether three airway clearance techniques ( Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate gastro-esophageal reflux in infants under the age of 1 year.
- Conditions
- Gastro-esophageal Reflux
- Being tested
- Assisted Autogenic Drainage (AAD), bouncing and AAD, bouncing
- Keywords
- gastro-esophageal reflux, GOR, GER, airway clearance techniques
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted Autogenic Drainage (AAD)Other
bouncing and AADOther
bouncingOther
| Study group | Role | What they receive |
|---|---|---|
| Assisted Autogenic Drainage (AAD) | Experimental | airway clearance technique for infants :Assisted Autogenic Drainage Receives: Other: Assisted Autogenic Drainage (AAD) |
| bouncing and AAD | Experimental | airway clearance technique for infants : bouncing combined with AAD Receives: Other: bouncing and AAD |
| bouncing | Experimental | bouncing . intervention to relax the infant Receives: Other: bouncing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Refluxes
number of refluxes will be counted over a period of 15 minutes ( treatment time )
Measured: 15 minutes
Secondary outcomes (1)
Duration of Reflux Episodes
duration of reflux episodes will be measured during 15 min of treatment time
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startSep 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastro-esophageal 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
- Single group
- Masking
- None (open label)
- Enrolment
- 159 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128867
- Sponsor's protocol ID
- FVG001
- Status last verified
- Mar 2015
- First submitted
- 23 Apr 2014
- Last updated
- 17 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Bouncing, Assisted Autogenic Drainage (AAD) and Bouncing and AAD (BAAD) on Gastro-oesophageal Reflux ( GOR ), Oxygen Saturation (SaO2) and Heart Rate in Infants From 0 to 12 Months
- ClinicalTrials.gov ID
- NCT02128867
- Acronym / sponsor ID
- FVG001
- Conditions
- Gastro-esophageal Reflux
- Keywords
- gastro-esophageal reflux, GOR, GER, airway clearance techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Posted 17 Mar 2015
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 three airway clearance techniques ( Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate gastro-esophageal reflux in infants under the age of 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Assisted Autogenic Drainage (AAD) | Experimental | Other: Assisted Autogenic Drainage (AAD)airway clearance technique for infants :Assisted Autogenic Drainage |
| bouncing and AAD | Experimental | Other: bouncing and AADairway clearance technique for infants : bouncing combined with AAD |
| bouncing | Experimental | Other: bouncingbouncing . intervention to relax the infant |
Who may qualify
- Ages
- 1 day to 365 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- infants < 1 year
- acid reflux monitoring
Key exclusion criteria (4 listed)
- gestational age <24 w
- anti-reflux medication
- Nissen fundoplication
- no parental consent
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 |
|---|---|---|
| Assisted Autogenic Drainage (AAD) | Other | Assisted Autogenic Drainage (AAD) |
| bouncing and AAD | Other | bouncing and AAD |
| bouncing | Other | bouncing |
Primary outcome
Number of Refluxes
Time frame: 15 minutes
number of refluxes will be counted over a period of 15 minutes ( treatment time )
1 secondary outcome
Duration of Reflux Episodes
Time frame: 15 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted Autogenic Drainage (AAD), bouncing and AAD and bouncing in people with Gastro-esophageal 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 2 inclusion and 4 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 Mar 2015. 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?
Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 15 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 Mar 2015.