Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT00373802
Status:
COMPLETED
Last Update Posted:
2009-01-12
First Post:
2006-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Nasal Phenylephrine in Infants With Bronchiolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001988', 'term': 'Bronchiolitis'}], 'ancestors': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010656', 'term': 'Phenylephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-09', 'studyFirstSubmitDate': '2006-09-07', 'studyFirstSubmitQcDate': '2006-09-07', 'lastUpdatePostDateStruct': {'date': '2009-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Distress Assessment Index at 5 minutes, 60 minutes, and 180 minutes.'}], 'secondaryOutcomes': [{'measure': 'Respiratory rate, oxygen saturation and use of supplemental oxygen at 5, 60, and 180 minutes.'}]}, 'conditionsModule': {'conditions': ['Bronchiolitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '4 Weeks', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 4 weeks to 12 months; admitting diagnosis of bronchiolitis; admitted to hospital's bronchiolitis pathway, admitted during weekdays, need for nasal suctioning.\n\nExclusion Criteria:\n\n* Congenital heart disease, history of hypertension, previous wheezing, prior use of inhaled corticosteroids, gestational age at birth of \\<34 weeks."}, 'identificationModule': {'nctId': 'NCT00373802', 'briefTitle': 'The Use of Nasal Phenylephrine in Infants With Bronchiolitis', 'organization': {'class': 'OTHER', 'fullName': "Akron Children's Hospital"}, 'officialTitle': 'A Randomized, Double-Blinded Placebo Control Trial of Nasal Phenylephrine in Infants With Bronchiolitis', 'orgStudyIdInfo': {'id': 'NASAL #9579'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Phenylephrine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rachel Konda-Sundheim, MD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center of Akron"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Akron Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Nathan Kraynack, M.D.', 'oldOrganization': "Akron Children's Hospital"}}}}