Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT02936518
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2016-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072676', 'term': 'Ankyloglossia'}, {'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'C000723647', 'term': 'lip tie'}], 'ancestors': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-19', 'studyFirstSubmitDate': '2016-10-14', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nipple pain', 'timeFrame': '1 week post-procedure'}, {'measure': 'Reflux (i-GERQ-R)', 'timeFrame': '1 week and 1 month post-procedure'}, {'measure': 'Maternal breastfeeding self-efficacy (BSES-SF)', 'timeFrame': '1 week and 1 month post-procedure'}]}, 'conditionsModule': {'keywords': ['ankyloglossia', 'breastfeeding', 'lip tie'], 'conditions': ['Ankyloglossia', 'Breastfeeding']}, 'referencesModule': {'references': [{'pmid': '23523198', 'type': 'BACKGROUND', 'citation': "O'Callahan C, Macary S, Clemente S. The effects of office-based frenotomy for anterior and posterior ankyloglossia on breastfeeding. Int J Pediatr Otorhinolaryngol. 2013 May;77(5):827-32. doi: 10.1016/j.ijporl.2013.02.022. Epub 2013 Mar 22."}, {'pmid': '18573859', 'type': 'BACKGROUND', 'citation': 'Geddes DT, Langton DB, Gollow I, Jacobs LA, Hartmann PE, Simmer K. Frenulotomy for breastfeeding infants with ankyloglossia: effect on milk removal and sucking mechanism as imaged by ultrasound. Pediatrics. 2008 Jul;122(1):e188-94. doi: 10.1542/peds.2007-2553. Epub 2008 Jun 23.'}, {'pmid': '27641715', 'type': 'BACKGROUND', 'citation': 'Ghaheri BA, Cole M, Fausel SC, Chuop M, Mace JC. Breastfeeding improvement following tongue-tie and lip-tie release: A prospective cohort study. Laryngoscope. 2017 May;127(5):1217-1223. doi: 10.1002/lary.26306. Epub 2016 Sep 19.'}]}, 'descriptionModule': {'briefSummary': 'A previously published study (https://www.ncbi.nlm.nih.gov/pubmed/27641715) identified breastfeeding improvements following lingual frenotomy and/or maxillary labial frenectomy. In the previous cohort, babies were excluded from the study if they had previously undergone an attempted frenotomy prior to seeing the P.I. in the office. The proposed study will only look at those babies who did undergo a previous frenotomy to determine:\n\n1. the presence of continued problematic breastfeeding symptoms\n2. if further tongue tie or lip tie release improves those outcomes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Months', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy babies who are breastfeeding\n* Had a previous frenotomy prior to presenting to the P.I.\n\nExclusion Criteria:\n\n* Twins, triplets\n* Maternal breast surgery or IGT\n* Premature birth\n* Significant heart/lung/brain disease of infant'}, 'identificationModule': {'nctId': 'NCT02936518', 'briefTitle': 'Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'The Oregon Clinic'}, 'officialTitle': 'Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'TOC ENT 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Procedure: Lingual frenotomy and/or maxillary labial frenectomy']}], 'interventions': [{'name': 'Lingual frenotomy and/or maxillary labial frenectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Oregon Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Otolaryngologist/Head and Neck Surgeon', 'investigatorFullName': 'Bobak Ghaheri, MD', 'investigatorAffiliation': 'The Oregon Clinic'}}}}