Gastroesophageal Reflux Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGOmeprazole 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)
Sponsors
Mansoura University Children Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 2 Years
Healthy volunteers
No
Inclusion criteria
* Infants with physician documented 3 attacks of wheezing episodes over the last 6 months or persistent wheeze over the last one month
Exclusion criteria
* Wheezy infants with atopy (allergic rhino-conjunctivitis or eczema), prematurity (less than 34 weeks), abnormal neurological examination, congenital heart diseases, airspace opacity on chest radiography, tracheal-bronchial malformations, immune deficiency and anatomical esophageal or gastric malformations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Each Level of Wheeze Control | 3 months | Number of Participants with controlled Wheezing Number of Participants with partially controlled Wheezing Number of Participants with uncontrolled wheezing |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | Omeprazole and Domperidone |
|---|---|
| Age, Categorical <=18 years | 52 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 9 months |
| Any positive test (combined MII-pH monitoring and/or endoscopic esophageal biopsy) negative | 14 Participants |
| Any positive test (combined MII-pH monitoring and/or endoscopic esophageal biopsy) positive | 38 Participants |
| combined multiple channels intraluminal impedence-pH (MII-pH) monitoring combined MII-pH negative | 18 Participants |
| combined multiple channels intraluminal impedence-pH (MII-pH) monitoring combined MII-pH positive | 34 Participants |
| esophageal biopsy no reflux esophagitis | 34 Participants |
| esophageal biopsy reflux esophagitis | 18 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 35 Participants |
| type of wheezing; persistent wheeze,intermittent wheeze intermittent wheeze | 25 Participants |
| type of wheezing; persistent wheeze,intermittent wheeze persistent wheeze | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
Time frame: 3 months
Population: Abnormal esophageal impedance-pH and or reflux esophagitis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | Number of Participants in Each Level of Wheeze Control | controlled | 18 Participants |
| Treatment Group | Number of Participants in Each Level of Wheeze Control | partially controlled | 11 Participants |
| Treatment Group | Number of Participants in Each Level of Wheeze Control | non controlled | 9 Participants |