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

NCT ID: NCT02936518

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Ankyloglossia Breastfeeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

Lingual frenotomy and/or maxillary labial frenectomy

Intervention Type PROCEDURE

Interventions

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Lingual frenotomy and/or maxillary labial frenectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Oregon Clinic

OTHER

Sponsor Role lead

Responsible Party

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Bobak Ghaheri, MD

Otolaryngologist/Head and Neck Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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O'Callahan C, Macary S, Clemente S. The effects of office-based frenotomy for anterior and posterior ankyloglossia on breastfeeding. Int J Pediatr Otorhinolaryngol. 2013 May;77(5):827-32. doi: 10.1016/j.ijporl.2013.02.022. Epub 2013 Mar 22.

Reference Type BACKGROUND
PMID: 23523198 (View on PubMed)

Geddes DT, Langton DB, Gollow I, Jacobs LA, Hartmann PE, Simmer K. Frenulotomy for breastfeeding infants with ankyloglossia: effect on milk removal and sucking mechanism as imaged by ultrasound. Pediatrics. 2008 Jul;122(1):e188-94. doi: 10.1542/peds.2007-2553. Epub 2008 Jun 23.

Reference Type BACKGROUND
PMID: 18573859 (View on PubMed)

Ghaheri BA, Cole M, Fausel SC, Chuop M, Mace JC. Breastfeeding improvement following tongue-tie and lip-tie release: A prospective cohort study. Laryngoscope. 2017 May;127(5):1217-1223. doi: 10.1002/lary.26306. Epub 2016 Sep 19.

Reference Type BACKGROUND
PMID: 27641715 (View on PubMed)

Other Identifiers

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TOC ENT 2

Identifier Type: -

Identifier Source: org_study_id