Bronchial Dilation Test in Wheezy Infants

Brochial Dilation Test by Salbutamol Metered Dose Inhaler(MDI) With Spacer in Wheezy Infants With Asthma Risk Factors

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03467776

Enrollment

Registered

2018-03-16

Start date

2018-07-31

Completion date

2019-12-31

Last updated

2018-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

infants, asthma, bronchial dilation test, plethysmography

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

5 Months to 36 Months

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
airway resistance(Raw) performed by body plethysmography before and after bronchial dilation test.	Change from baseline at 20 mins after inhalation of salbutamol	airway resistance(Raw) at rest

Secondary

Measure	Time frame	Description
airway resistance(Raw) performed by body plethysmography	at 24 hours of the exacerbation of wheeze	airway resistance(Raw) measured within 24 hours whenever there is an exacerbation of wheeze.

Countries

China

Outcome results