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The Use of Nasal Phenylephrine in Infants With Bronchiolitis

This study has been completed.
Sponsor:
Information provided by:
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00373802
First received: September 7, 2006
Last updated: January 9, 2009
Last verified: January 2009
History of Changes
  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
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:

U.S. FDA Resources

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

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nathan Kraynack, M.D., Akron Children's Hospital
ClinicalTrials.gov 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:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Phenylephrine
Oxymetazoline
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013