Breastfeeding Improvement Following Tongue-tie and Lip-tie Release

Not Applicable

Completed

• Conditions: Breastfeeding; Ankyloglossia
• Interventions: Procedure: Lingual Frenotomy and/or maxillary labial frenectomy

• Registration Number: NCT02642133
• Lead Sponsor: The Oregon Clinic

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-03
• Status Verified: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2015-12-29
• Last Update Submitted: 2015-12-29
• Study First Posted: 2015-12-30
• Last Update Posted: 2015-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Lingual Frenotomy and/or maxillary labial frenectomy	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.

Primary Outcome Measures

Name	Time	Method
Reflux/GERD	1 week	Using a validated questionnaire (i-GERQ-R)
Nipple Pain	1 week	Using a visual analog scale, nipple pain is evaluated.
Breastfeeding efficiency	1 week	Volume of breastmilk ingested in a specific time frame calculated (mL/min)
Breastfeeding self-efficacy	1 week	Uses the BSES-SF validated questionnaire

Secondary Outcome Measures

Name	Time	Method
Reflux/GERD	1 month	Using a validated questionnaire (i-GERQ-R)
Nipple Pain	1 month	Using a visual analog scale, nipple pain is evaluated.
Breastfeeding self-efficacy	1 month	Uses the BSES-SF validated questionnaire