Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assisted Autogenic Drainage (AAD) | Experimental | airway clearance technique for infants :Assisted Autogenic Drainage |
|
| bouncing and AAD | Experimental | airway clearance technique for infants : bouncing combined with AAD |
|
| bouncing | Experimental | bouncing . intervention to relax the infant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assisted Autogenic Drainage (AAD) | Other |
| ||
| bouncing and AAD |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Refluxes | number of refluxes will be counted over a period of 15 minutes ( treatment time ) | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Reflux Episodes | duration of reflux episodes will be measured during 15 min of treatment time | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Heartrate | heartrate will be measured during 15 min of treatment time | 15 minutes |
| Sa02 | SaO2 will be measured during 15 minutes of treatment time |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZBrussel | Jette | Brussels Capital | 1090 | Belgium |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Assisted Autogenic Drainage (AAD) | airway clearance technique for infants :Assisted Autogenic Drainage Assisted Autogenic Drainage (AAD) |
| FG001 | Bouncing Combined With AAD | airway clearance technique for infants : bouncing combined with AAD bouncing combined with AAD |
| FG002 | Bouncing | bouncing as control group. intervention to relax the infant bouncing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Assisted Autogenic Drainage (AAD) | airway clearance technique for infants :Assisted Autogenic Drainage Assisted Autogenic Drainage (AAD) |
| BG001 | Bouncing Combined With AAD | airway clearance technique for infants : bouncing combined with AAD bouncing combined with AAD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Refluxes | number of refluxes will be counted over a period of 15 minutes ( treatment time ) | Posted | Mean | Standard Deviation | number of refluxes | 15 minutes |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Assisted Autogenic Drainage (AAD) | airway clearance technique for infants :Assisted Autogenic Drainage Assisted Autogenic Drainage (AAD) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| filip van ginderdeuren | vrije universiteit brussel | +3224763916 | filip.vanginderdeuren@uzbrussel.be |
Not provided
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
| bouncing | Other |
|
| 15 minutes |
| BG002 | Bouncing | bouncing . intervention to relax the infant bouncing |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
bouncing as control group. intervention to relax the infant
bouncing
|
|
| Secondary | Duration of Reflux Episodes | duration of reflux episodes will be measured during 15 min of treatment time | Not Posted | 15 minutes |
| Other Pre-specified | Heartrate | heartrate will be measured during 15 min of treatment time | Not Posted | 15 minutes |
| Other Pre-specified | Sa02 | SaO2 will be measured during 15 minutes of treatment time | Not Posted | 15 minutes |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Bouncing Combined With AAD | airway clearance technique for infants : bouncing combined with AAD bouncing combined with AAD | 0 | 52 | 0 | 52 |
| EG002 | Bouncing | bouncing as control group. intervention to relax the infant bouncing | 0 | 54 | 0 | 54 |
Not provided
Not provided
| D004066 | Digestive System Diseases |