Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-03-10 @ 11:45 PM
Study NCT ID:
NCT03288857
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2017-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-18', 'studyFirstSubmitDate': '2017-09-13', 'studyFirstSubmitQcDate': '2017-09-15', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unscheduled bronchiolitis return visits', 'timeFrame': '14 days', 'description': 'The number of unscheduled bronchiolitis return visits (return to either ED, urgent care or PCP)'}], 'secondaryOutcomes': [{'measure': 'Oral intake', 'timeFrame': '14 days', 'description': 'Effects of device on oral intake as determined by diary and post-study questionnaire'}, {'measure': 'Respiratory relief', 'timeFrame': '14 days', 'description': 'Effects of device on respiratory relief as determined by diary and post-study questionnaire'}, {'measure': 'Parental device preference', 'timeFrame': '14 days', 'description': 'Parental device preference as determined by diary and post-study questionnaire'}, {'measure': 'Adverse events', 'timeFrame': '14 days', 'description': 'Description of adverse events as determined by diary and post-study questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Naspira', 'Suctioning', 'Nasal suction device', 'Children'], 'conditions': ['Bronchiolitis', 'Aspirator']}, 'referencesModule': {'references': [{'pmid': '35100758', 'type': 'DERIVED', 'citation': 'Schwarz WW, Wilkinson M, Allen A. Randomized Controlled Trial Comparing the Bulb Aspirator With a Nasal-Oral Aspirator in the Treatment of Bronchiolitis. Pediatr Emerg Care. 2022 Feb 1;38(2):e529-e533. doi: 10.1097/PEC.0000000000002372.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to compare the standard bulb aspirator with that of a nasal oral aspirator. The hypothesis is that use of a nasal oral aspirator is more effective at removing nasal secretions in the treatment of bronchiolitis as measured by a predicted 50% decrease in the rate of unscheduled bronchiolitis return visits. The primary endpoint will be the number of unscheduled bronchiolitis return visits; secondary endpoints will include measurements of oral intake, respiratory relief, parental device preference and adverse events.', 'detailedDescription': "This study will be a single center, single blind, randomized controlled trial in the pediatric emergency department (ED) at Dell Children's Medical Center of Central Texas (DCMC). An ED discharge diagnosis of bronchiolitis will trigger patients to be randomized to receive a bulb aspirator or nasal oral aspirator for home secretion management use. Prior to dispensing the randomized aspirator, a pre-distribution questionnaire will be administered. Additionally, patients will receive a diary to complete for 3 days post ED discharge. Research personnel will call families on day 4 as a reminder to return the diary and again on day 14 to obtain a verbal post-study questionnaire. Research personnel will perform chart review on all patients looking for unscheduled patient return visits for bronchiolitis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '1 Month', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children \\>28 days of life to \\< 2 years of age discharged home from the DCMC ED with a diagnosis of bronchiolitis (diagnosis made per provider discretion)\n* Caregiver fluent in English or Spanish\n\nExclusion Criteria:\n\n* Previous enrollment\n* Hospital admission\n* Parental refusal to be randomized to an aspirator device (i.e., family prefers current device and does not wish to be randomized to a potentially different product)\n* Current bacterial pneumonia\n* Diagnosis of asthma\n* Chronic lung disease\n* Significant underlying cardiac disease\n* Chronic neuromuscular disease'}, 'identificationModule': {'nctId': 'NCT03288857', 'briefTitle': 'Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis', 'orgStudyIdInfo': {'id': '2017-06-0086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Bulb Aspirator', 'description': 'If randomized to the bulb aspirator group, the patient will be sent home with a bulb aspirator to use for home nasal secretion management'}, {'type': 'EXPERIMENTAL', 'label': 'Nasal Oral Aspirator (NeilMed Naspira)', 'description': 'If randomized to the nasal oral aspirator group, patient will be sent home with a nasal oral aspirator to use for home nasal secretion management', 'interventionNames': ['Device: NeilMed Naspira']}], 'interventions': [{'name': 'NeilMed Naspira', 'type': 'DEVICE', 'description': 'NeilMed Naspira is a nasal-oral aspirator', 'armGroupLabels': ['Nasal Oral Aspirator (NeilMed Naspira)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78723', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': "Dell Children's Medical Center of Central Texas", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'collaborators': [{'name': "Dell Children's Medical Center of Central Texas", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Whitney Schwarz', 'investigatorAffiliation': 'University of Texas at Austin'}}}}