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

September 19, 2017 updated by: Bobak Ghaheri, MD, The Oregon Clinic

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 8 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Procedure: Lingual frenotomy and/or maxillary labial frenectomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Oregon Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

September 20, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOC ENT 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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