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Wheezy infants were tested for gastro-esophageal reflux disease (GERD) using combined multiple channel intraluminal impedance-pH (MII-pH), esophagogastroduodenoscope (EGD), lipid laden macrophage index and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux esophagitis were given domperidone and omeprazole then re-evaluated for symptoms control and exacerbations recurrence.
Wheezy infants were tested for gastro-esophageal reflux disease using combined MII-pH, EGD, LLMI and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux esophagitis were given domperidone and omeprazole for 12 weeks then re-evaluated for symptoms control and wheeze exacerbations recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| omeprazole and domperidone | Other | wheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole and domperidone | Drug | wheezy infants with abnormal MII-pH or reflux esophagitis will be given omeprazol(10mg/once/day) and domperidone (0.2mg/kg/day t.d.s) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Each Level of Wheeze Control | Number of Participants with controlled Wheezing Number of Participants with partially controlled Wheezing Number of Participants with uncontrolled wheezing | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tarek El-Desoky | Faculty if medicine, Mansoura University | Study Director |
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infants referred to the pediatric pulmonology unit at MUCH for evaluation because of recurrent or persistent wheeze were evaluated for the presence of GERD at gastro-enterology and hepatology unit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omeprazole and Domperidone | wheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omeprazole and Domperidone | wheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day). |
| 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 Participants in Each Level of Wheeze Control | Number of Participants with controlled Wheezing Number of Participants with partially controlled Wheezing Number of Participants with uncontrolled wheezing | Abnormal esophageal impedance-pH and or reflux esophagitis | Posted | Count of Participants | Participants | 3 months |
|
|
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"Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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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 | Omeprazole and Domperidone | wheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day). Omeprazole and domperidone: wheezy infants with abnormal MII-pH or reflux esophagitis will be given omeprazol(10mg/once/day) and domperidone (0.2mg/kg/day t.d.s) |
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Non randomization
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Ahmed Zaki | Manicure university children hospital | 0201008335567 | drahmedmd17@yahoo.com |
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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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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Participants |
|
| Age, Continuous | Median | Full Range | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| type of wheezing; persistent wheeze,intermittent wheeze | persistent wheeze: wheeze for 1 month intermittent wheeze,: 3 wheeze episodes in 6 months | Count of Participants | Participants |
|
| combined multiple channels intraluminal impedence-pH (MII-pH) monitoring | positive combined multiple channels intraluminal impedence-pH (MII-pH) monitoring. negative combined multiple channels intraluminal impedence-pH (MII-pH) monitoring. | Count of Participants | Participants |
|
| esophageal biopsy | reflux esophagitis no reflux esophagitis | Count of Participants | Participants |
|
| Any positive test (combined MII-pH monitoring and/or endoscopic esophageal biopsy) | positive combined MII-pH monitoring and/or endoscopic esophageal biopsy. negative combined MII-pH monitoring and/or endoscopic esophageal biopsy | Count of Participants | Participants |
|
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| 0 |
| 0 |
| 0 |
| 0 |
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| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010880 | Piperidines |