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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02936518
Other study ID # TOC ENT 2
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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