Trial Outcomes & Findings for Role of Pepsin Assay in Wheezy Infants (NCT NCT02685436)

Last Updated: 2019-10-07

Results Overview

Number of Participants with controlled Wheezing Number of Participants with partially controlled Wheezing Number of Participants with uncontrolled wheezing

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

3 months

Results posted on

2019-10-07

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	52
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Pepsin Assay in Wheezy Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omeprazole and Domperidone n=52 Participants wheezy infants with GERD will receive 12 weeks of domperidone (0.2mg/kg/day t.d.s.) and omeprazole (10 mg/once/day).
Age, Categorical <=18 years	52 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	9 months n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
type of wheezing; persistent wheeze,intermittent wheeze persistent wheeze	27 Participants n=5 Participants
type of wheezing; persistent wheeze,intermittent wheeze intermittent wheeze	25 Participants n=5 Participants
combined multiple channels intraluminal impedence-pH (MII-pH) monitoring combined MII-pH positive	34 Participants n=5 Participants
combined multiple channels intraluminal impedence-pH (MII-pH) monitoring combined MII-pH negative	18 Participants n=5 Participants
esophageal biopsy reflux esophagitis	18 Participants n=5 Participants
esophageal biopsy no reflux esophagitis	34 Participants n=5 Participants
Any positive test (combined MII-pH monitoring and/or endoscopic esophageal biopsy) positive	38 Participants n=5 Participants
Any positive test (combined MII-pH monitoring and/or endoscopic esophageal biopsy) negative	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Abnormal esophageal impedance-pH and or reflux esophagitis

Number of Participants with controlled Wheezing Number of Participants with partially controlled Wheezing Number of Participants with uncontrolled wheezing

Outcome measures

Outcome measures
Measure	Treatment Group n=38 Participants a wheezy infant with positive combined MII-pH and/or reflux esophagitis
Number of Participants in Each Level of Wheeze Control partially controlled	11 Participants
Number of Participants in Each Level of Wheeze Control non controlled	9 Participants
Number of Participants in Each Level of Wheeze Control controlled	18 Participants

Adverse Events

Omeprazole and Domperidone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Ahmed Zaki

Manicure university children hospital

Phone: 0201008335567

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place