NCT00373802

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
Last Updated

January 12, 2009

Status Verified

January 1, 2009

Enrollment Period

5 months

First QC Date

September 7, 2006

Last Update Submit

January 9, 2009

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

PhenylephrineDRUG

Eligibility Criteria

Age4 Weeks - 12 Months
Sexall
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bronchiolitis

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Rachel Konda-Sundheim, MD, MD

    Children's Hospital Medical Center of Akron

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 8, 2006

Study Start

January 1, 2005

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

January 12, 2009

Record last verified: 2009-01