The Use of Nasal Phenylephrine in Infants With Bronchiolitis | NCT00373802

Studies
The Use of Nasal Phenylephrine in Infants With Bronchiolitis

NCT00373802

Sponsor

Akron Children's Hospital

Status

Completed

Last Update Posted

Jan 12, 2009Estimated

Enrollment

Phase

Phase 2

Conditions

Bronchiolitis

Interventions

Phenylephrine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Sep 7, 2006

First Submission Date that Met QC Criteria

Sep 7, 2006

First Posted Date

Sep 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2009

Last Update Posted Date

Jan 12, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Phenylephrine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Respiratory Distress Assessment Index at 5 minutes, 60 minutes, and 180 minutes.

Secondary Outcomes

Measure	Description	Time Frame
Respiratory rate, oxygen saturation and use of supplemental oxygen at 5, 60, and 180 minutes.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Weeks

Maximum Age

12 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachel Konda-Sundheim, MD, MD	Children's Hospital Medical Center of Akron	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001988	Bronchiolitis

Ancestor Terms

ID	Term
D001991	Bronchitis
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010656	Phenylephrine

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided