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The Use of Nasal Phenylephrine in Infants With Bronchiolitis

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Phenylephrine
Sponsored by
Akron Children's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis

Eligibility Criteria

4 Weeks - 12 Months (Child)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Respiratory Distress Assessment Index at 5 minutes, 60 minutes, and 180 minutes.

    Secondary Outcome Measures

    Respiratory rate, oxygen saturation and use of supplemental oxygen at 5, 60, and 180 minutes.

    Full Information

    First Posted
    September 7, 2006
    Last Updated
    January 9, 2009
    Sponsor
    Akron Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00373802
    Brief Title
    The Use of Nasal Phenylephrine in Infants With Bronchiolitis
    Official Title
    A Randomized, Double-Blinded Placebo Control Trial of Nasal Phenylephrine in Infants With Bronchiolitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    June 2005 (Actual)
    Study Completion Date
    June 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Akron Children's Hospital

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchiolitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    50 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Phenylephrine
    Primary Outcome Measure Information:
    Title
    Respiratory Distress Assessment Index at 5 minutes, 60 minutes, and 180 minutes.
    Secondary Outcome Measure Information:
    Title
    Respiratory rate, oxygen saturation and use of supplemental oxygen at 5, 60, and 180 minutes.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Weeks
    Maximum Age & Unit of Time
    12 Months
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rachel Konda-Sundheim, MD, MD
    Organizational Affiliation
    Children's Hospital Medical Center of Akron
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Use of Nasal Phenylephrine in Infants With Bronchiolitis

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