The Use of Nasal Phenylephrine in Infants With Bronchiolitis

This study has been completed.
Information provided by:
Akron Children's Hospital Identifier:
First received: September 7, 2006
Last updated: January 9, 2009
Last verified: January 2009
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
Drug: Phenylephrine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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)

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both

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.
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Please refer to this study by its identifier: NCT00373802

Sponsors and Collaborators
Akron Children's Hospital
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 Identifier: NCT00373802     History of Changes
Other Study ID Numbers: NASAL #9579 
Study First Received: September 7, 2006
Last Updated: January 9, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Autonomic Agents
Cardiotonic Agents
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Vasoconstrictor Agents processed this record on May 24, 2016