Bronchial Dilation Test in Wheezy Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-12-31

Brief Summary

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The purpose of the study is to establish the methodology of bronchial dilation test by salbutamol MDI with Spacer in wheezy infants with asthma and to evaluate the effects of atopy on the exacerbation of wheeze in wheezy infants.

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Detailed Description

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After screening,each participant undergo baseline pulmonary function test(Jaeger Master Screen Baby Body, Germany)and post-bronchodilator measurements that performed 10min after 200ug of salbutamol administered using a metered-dose inhaler and a spacer.

The participants undergo baseline lung function test and bronchial dilation tests on the second and third visits with one-month interval,and whenever there is an exacerbation.

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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healthy

healthy control, 5 months to 3 years

No interventions assigned to this group

wheezing with atopy

suspected asthma with wheezing (\>3 episodes per year) and atopy

No interventions assigned to this group

wheezing without atopy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* normal term infants.Recurrent wheezing with or without atopy,none of the subjects had a history of respiratory illness, congenital heart disease,dysphagia,oxygen saturation≤90% on room air,an active seizure disorder,or upper airway obstruction,or requirement for assisted ventilation in the neonatal periods,all infants were asymptomatic for at least 2 weeks preceding the test.

Exclusion Criteria

* subjects had a history of respiratory illness, congenital heart disease,dysphagia,oxygen saturation≤90% on room air,an active seizure disorder,or upper airway obstruction,;all infants were asymptomatic for at least 2 weeks preceding the test.

Minimum Eligible Age

5 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes