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The Use of Nasal Phenylephrine in Infants With Bronchiolitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373802
First Posted: September 8, 2006
Last Update Posted: January 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Akron Children's Hospital
  Purpose
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.

Condition Intervention Phase
Bronchiolitis Drug: Phenylephrine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded Placebo Control Trial of Nasal Phenylephrine in Infants With Bronchiolitis

Resource links provided by NLM:


Further study details as provided by Akron Children's Hospital:

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.

Estimated Enrollment: 50
Study Start Date: January 2005
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373802


Sponsors and Collaborators
Akron Children's Hospital
Investigators
Principal Investigator: Rachel Konda-Sundheim, MD, MD Children's Hospital Medical Center of Akron
  More Information

Responsible Party: Nathan Kraynack, M.D., Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00373802     History of Changes
Other Study ID Numbers: NASAL #9579
First Submitted: September 7, 2006
First Posted: September 8, 2006
Last Update Posted: January 12, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Phenylephrine
Oxymetazoline
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents