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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrapulmonary Percussive Ventilation | Experimental | number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrapulmonary Percussive Ventilation | Device | 20 min IPV freq 300/min, p 10cmH2O |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Refluxes | Every two hours after feeding, the number of refluxes during 20 minutes are measured. The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV | during 20 minutes of IPV compared to mean number of refluxes during 20 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| fili van ginderdeuren | Vrije Universiteit Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Jette | Brussels Capital | 1090 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intrapulmonary Percussive Ventilation | number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intrapulmonary Percussive Ventilation | number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O |
| 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 | Every two hours after feeding, the number of refluxes during 20 minutes are measured. The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV | All patients receiving IPV were their own controls | Posted | Mean | Standard Deviation | number of refluxes | during 20 minutes of IPV compared to mean number of refluxes during 20 minutes. |
|
20 minutes
during treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intrapulmonary Percussive Ventilation | number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| filip van ginderdeuren | vrije universiteit brussel | +3224763916 | filip.vanginderdeuren@telenet.be |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
mean number of refluxes during 20 min, 120 min after each meal
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | Control | mean number of refluxes during 20 min, 120 min after each meal | 0 | 67 | 0 | 67 |
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| D004066 | Digestive System Diseases |