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

Not Applicable

Completed

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

• Registration Number: NCT02936518
• Lead Sponsor: The Oregon Clinic

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-04
• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Study Completion: 2017-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Lingual frenotomy and/or maxillary labial frenectomy	-

Primary Outcome Measures

Name	Time	Method
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