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The Use of Nasal Phenylephrine in Infants With Bronchiolitis

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. Identifier: NCT00373802
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : January 12, 2009
Information provided by:
Akron Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Drug: Phenylephrine Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
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
Study Start Date : January 2005
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Respiratory Distress Assessment Index at 5 minutes, 60 minutes, and 180 minutes.

Secondary Outcome Measures :
  1. Respiratory rate, oxygen saturation and use of supplemental oxygen at 5, 60, and 180 minutes.

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

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.

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 identifier (NCT number): NCT00373802

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

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Responsible Party: Nathan Kraynack, M.D., Akron Children's Hospital Identifier: NCT00373802    
Other Study ID Numbers: NASAL #9579
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: January 12, 2009
Last Verified: January 2009
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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