Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study
1 other identifier
interventional
55
0 countries
N/A
Brief Summary
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:
- 1.the presence of continued problematic breastfeeding symptoms
- 2.if further tongue tie or lip tie release improves those outcomes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 14, 2016
CompletedFirst Posted
Study publicly available on registry
October 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedSeptember 20, 2017
September 1, 2017
10 months
October 14, 2016
September 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Nipple pain
1 week post-procedure
Reflux (i-GERQ-R)
1 week and 1 month post-procedure
Maternal breastfeeding self-efficacy (BSES-SF)
1 week and 1 month post-procedure
Study Arms (1)
Intervention
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy babies who are breastfeeding
- Had a previous frenotomy prior to presenting to the P.I.
You may not qualify if:
- Twins, triplets
- Maternal breast surgery or IGT
- Premature birth
- Significant heart/lung/brain disease of infant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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: 23523198BACKGROUNDGeddes 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: 18573859BACKGROUNDGhaheri 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.
PMID: 27641715BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Otolaryngologist/Head and Neck Surgeon
Study Record Dates
First Submitted
October 14, 2016
First Posted
October 18, 2016
Study Start
June 1, 2014
Primary Completion
April 1, 2015
Study Completion
June 1, 2017
Last Updated
September 20, 2017
Record last verified: 2017-09