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

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

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Key information

Conditions

Ankyloglossia Behavior Breast Feeding Breastfeeding Feeding Behavior Stomatognathic Diseases lip tie

Age range

1 day–8 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lingual frenotomy and/or maxillary labial frenectomy

Procedure

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

The Oregon Clinic

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2017
First posted: Oct 18, 2016
Registry last updated: Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed