Breastfeeding Improvement Following Tongue-tie and Lip-tie Release

Breastfeeding Clinical Trial

Official title:

Breastfeeding Improvement Following Tongue-tie and Lip-tie Release: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642133
• Other study ID #: TOC ENT
• Status: Completed
• Phase: N/A
• First received: December 22, 2015
• Last updated: December 29, 2015
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: The Oregon Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Clinically, 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.

This study aims to prospectively analyze these outcomes by using validated tools.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Weeks

Eligibility

Inclusion Criteria:

• Healthy babies who are breastfeeding 0-12 weeks of age

Exclusion Criteria:

• Serious comorbid conditions (heart, lung, brain)

• Prior maternal breast surgery

• Insufficient glandular tissue

• Previous tongue/lip surgery

• Twins/Triplets

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankyloglossia
• Breastfeeding

Intervention

Procedure:
• Lingual Frenotomy and/or maxillary labial frenectomy
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.

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nipple Pain	Using a visual analog scale, nipple pain is evaluated.	1 week	No
Primary	Reflux/GERD	Using a validated questionnaire (i-GERQ-R)	1 week	No
Primary	Breastfeeding efficiency	Volume of breastmilk ingested in a specific time frame calculated (mL/min)	1 week	No
Primary	Breastfeeding self-efficacy	Uses the BSES-SF validated questionnaire	1 week	No
Secondary	Nipple Pain	Using a visual analog scale, nipple pain is evaluated.	1 month	No
Secondary	Reflux/GERD	Using a validated questionnaire (i-GERQ-R)	1 month	No
Secondary	Breastfeeding self-efficacy	Uses the BSES-SF validated questionnaire	1 month	No