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NCT00373802 Clinical Trial

The Use of Nasal Phenylephrine in Infants With Bronchiolitis

Bronchiolitis Clinical Trial

Official title:
A Randomized, Double-Blinded Placebo Control Trial of Nasal Phenylephrine in Infants With Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00373802
Other study ID # NASAL #9579
Secondary ID
Status Completed
Phase Phase 2
First received September 7, 2006
Last updated January 9, 2009
Start date January 2005
Est. completion date June 2005

Study information
Verified date January 2009
Source Akron Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Drops of either saline or phenylephrine are placed in the nose of infants less than 12 months of age to determine if it helps them to breathe easier.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 2005
Est. primary completion date June 2005
Accepts healthy volunteers
Gender Both
Age group N/A to 12 Months
Eligibility Inclusion Criteria:

- Age 4 weeks to 12 months; admitting diagnosis of bronchiolitis; admitted to hospital's bronchiolitis pathway, admitted during weekdays, need for nasal suctioning.

Exclusion Criteria:

- Congenital heart disease, history of hypertension, previous wheezing, prior use of inhaled corticosteroids, gestational age at birth of <34 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Phenylephrine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Akron Children's Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Respiratory Distress Assessment Index at 5 minutes, 60 minutes, and 180 minutes.
Secondary Respiratory rate, oxygen saturation and use of supplemental oxygen at 5, 60, and 180 minutes.
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