Overview

This trial is active, not recruiting.

Conditions ankyloglossia, breastfeeding, lip tie
Treatment lingual frenotomy and/or maxillary labial frenectomy
Sponsor The Oregon Clinic
Start date June 2014
End date April 2015
Trial size 55 participants
Trial identifier NCT02936518, TOC ENT 2

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
lingual frenotomy and/or maxillary labial frenectomy

Primary Outcomes

Measure
Nipple pain
time frame: 1 week post-procedure
Reflux (i-GERQ-R)
time frame: 1 week and 1 month post-procedure
Maternal breastfeeding self-efficacy (BSES-SF)
time frame: 1 week and 1 month post-procedure

Eligibility Criteria

Male or female participants up to 8 months old.

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

Additional Information

Official title Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by The Oregon Clinic.