Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-02-21 @ 2:32 PM
Study NCT ID:
NCT02642133
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2015-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breastfeeding Improvement Following Tongue-tie and Lip-tie Release
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072676', 'term': 'Ankyloglossia'}, {'id': 'D001942', 'term': 'Breast Feeding'}], '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': 'ACTUAL', 'count': 237}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-29', 'studyFirstSubmitDate': '2015-12-22', 'studyFirstSubmitQcDate': '2015-12-29', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nipple Pain', 'timeFrame': '1 week', 'description': 'Using a visual analog scale, nipple pain is evaluated.'}, {'measure': 'Reflux/GERD', 'timeFrame': '1 week', 'description': 'Using a validated questionnaire (i-GERQ-R)'}, {'measure': 'Breastfeeding efficiency', 'timeFrame': '1 week', 'description': 'Volume of breastmilk ingested in a specific time frame calculated (mL/min)'}, {'measure': 'Breastfeeding self-efficacy', 'timeFrame': '1 week', 'description': 'Uses the BSES-SF validated questionnaire'}], 'secondaryOutcomes': [{'measure': 'Nipple Pain', 'timeFrame': '1 month', 'description': 'Using a visual analog scale, nipple pain is evaluated.'}, {'measure': 'Reflux/GERD', 'timeFrame': '1 month', 'description': 'Using a validated questionnaire (i-GERQ-R)'}, {'measure': 'Breastfeeding self-efficacy', 'timeFrame': '1 month', 'description': 'Uses the BSES-SF validated questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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': '26255605', 'type': 'BACKGROUND', 'citation': 'Pransky SM, Lago D, Hong P. Breastfeeding difficulties and oral cavity anomalies: The influence of posterior ankyloglossia and upper-lip ties. Int J Pediatr Otorhinolaryngol. 2015 Oct;79(10):1714-7. doi: 10.1016/j.ijporl.2015.07.033. Epub 2015 Jul 31.'}, {'pmid': '27641715', 'type': 'DERIVED', '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': 'This study is an observational study to determine outcomes of surgical release of tongue-tie and lip-tie in babies who are experiencing difficulty with breastfeeding.', 'detailedDescription': 'Breastfeeding rates in the United States initiate at around 80%, but many mothers are unable to effectively breastfeeding because of problems with latch and suction generation. Previous studies have demonstrated how nipple pain is directly linked to ankyloglossia, but most of these studies are done with poor methodology.\n\nClinically, tongue-tie and lip-tie have correlate with numerous other symptoms besides nipple pain. These babies tend to be inefficient nursers, which can affect weight gain. Abnormal intake of air because of the poor latch/seal can lead to reflux symptoms. Finally, there is a significant psychological toll on mothers who want to breastfeed but cannot do so.\n\nThis study aims to prospectively analyze these outcomes by using validated tools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy babies who are breastfeeding 0-12 weeks of age\n\nExclusion Criteria:\n\n* Serious comorbid conditions (heart, lung, brain)\n* Prior maternal breast surgery\n* Insufficient glandular tissue\n* Previous tongue/lip surgery\n* Twins/Triplets'}, 'identificationModule': {'nctId': 'NCT02642133', 'briefTitle': 'Breastfeeding Improvement Following Tongue-tie and Lip-tie Release', 'organization': {'class': 'OTHER', 'fullName': 'The Oregon Clinic'}, 'officialTitle': 'Breastfeeding Improvement Following Tongue-tie and Lip-tie Release: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'TOC ENT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'All patients were in the same arm - this is a cohort study where the group serves as their own control. Patients who did not undergo the procedure were not included in this outcomes study.', 'interventionNames': ['Procedure: Lingual Frenotomy and/or maxillary labial frenectomy']}], 'interventions': [{'name': 'Lingual Frenotomy and/or maxillary labial frenectomy', 'type': 'PROCEDURE', 'description': 'The procedure is performed with a 1064nm InGaAsP semiconductor diode laser which is a soft tissue laser with variable pulsed wave and wattage settings. The procedure was performed at 0.7-0.8 pulsed watts, 200 microseconds on and 100 microseconds off (actual wattage: 0.47 to 0.53 W) using a 300 micron laser fiber. The tongue is elevated using a grooved director while the laser tip is applied to the frenulum. If present, the anterior frenulum is divided until the submucosal portion of the tie is identified (this is the posterior tongue-tie). A small window in the central mucosa is made and the lateral mucosal walls of the posterior tongue-tie are released, taking care to not disturb the fascia of the underlying genioglossus muscle.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bobak A Ghaheri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Oregon Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Oregon Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Otolaryngologist', 'investigatorFullName': 'Bobak Ghaheri, MD', 'investigatorAffiliation': 'The Oregon Clinic'}}}}