Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study

Breastfeeding Clinical Trial

Official title:

Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02936518
• Other study ID #: TOC ENT 2
• Status: Completed
• Phase: N/A
• First received: October 14, 2016
• Last updated: September 19, 2017
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: The Oregon Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 8 Months

Eligibility

Inclusion Criteria:

• Healthy babies who are breastfeeding

• Had a previous frenotomy prior to presenting to the P.I.

Exclusion Criteria:

• Twins, triplets

• Maternal breast surgery or IGT

• Premature birth

• Significant heart/lung/brain disease of infant

Related Conditions & MeSH terms

• Ankyloglossia
• Breastfeeding

Intervention

Procedure:
• Lingual frenotomy and/or maxillary labial frenectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Oregon Clinic

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nipple pain		1 week post-procedure
Primary	Reflux (i-GERQ-R)		1 week and 1 month post-procedure
Primary	Maternal breastfeeding self-efficacy (BSES-SF)		1 week and 1 month post-procedure