NCT02642133

Brief Summary

This study is an observational study to determine outcomes of surgical release of tongue-tie and lip-tie in babies who are experiencing difficulty with breastfeeding.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

9 months

First QC Date

December 22, 2015

Last Update Submit

December 29, 2015

Conditions

AnkyloglossiaBreastfeeding

Outcome Measures

Primary Outcomes (4)

  • Nipple Pain

    Using a visual analog scale, nipple pain is evaluated.

    1 week

  • Reflux/GERD

    Using a validated questionnaire (i-GERQ-R)

    1 week

  • Breastfeeding efficiency

    Volume of breastmilk ingested in a specific time frame calculated (mL/min)

    1 week

  • Breastfeeding self-efficacy

    Uses the BSES-SF validated questionnaire

    1 week

Secondary Outcomes (3)

  • Nipple Pain

    1 month

  • Reflux/GERD

    1 month

  • Breastfeeding self-efficacy

    1 month

Study Arms (1)

Intervention

OTHER

All patients were in the same arm - this is a cohort study where the group serves as their own control. Patients who did not undergo the procedure were not included in this outcomes study.

Procedure: Lingual Frenotomy and/or maxillary labial frenectomy

Interventions

Lingual Frenotomy and/or maxillary labial frenectomyPROCEDURE

The procedure is performed with a 1064nm InGaAsP semiconductor diode laser which is a soft tissue laser with variable pulsed wave and wattage settings. The procedure was performed at 0.7-0.8 pulsed watts, 200 microseconds on and 100 microseconds off (actual wattage: 0.47 to 0.53 W) using a 300 micron laser fiber. The tongue is elevated using a grooved director while the laser tip is applied to the frenulum. If present, the anterior frenulum is divided until the submucosal portion of the tie is identified (this is the posterior tongue-tie). A small window in the central mucosa is made and the lateral mucosal walls of the posterior tongue-tie are released, taking care to not disturb the fascia of the underlying genioglossus muscle.

Intervention

Eligibility Criteria

Age1 Day - 12 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy babies who are breastfeeding 0-12 weeks of age

You may not qualify if:

  • Serious comorbid conditions (heart, lung, brain)
  • Prior maternal breast surgery
  • Insufficient glandular tissue
  • Previous tongue/lip surgery
  • Twins/Triplets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 23523198BACKGROUND

  • 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.

    PMID: 18573859BACKGROUND

  • Pransky SM, Lago D, Hong P. Breastfeeding difficulties and oral cavity anomalies: The influence of posterior ankyloglossia and upper-lip ties. Int J Pediatr Otorhinolaryngol. 2015 Oct;79(10):1714-7. doi: 10.1016/j.ijporl.2015.07.033. Epub 2015 Jul 31.

    PMID: 26255605BACKGROUND

  • 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.

    PMID: 27641715DERIVED

MeSH Terms

Conditions

AnkyloglossiaBreast Feeding

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesFeeding BehaviorBehavior

Study Officials

  • Bobak A Ghaheri, MD

    The Oregon Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Otolaryngologist

Study Record Dates

First Submitted

December 22, 2015

First Posted

December 30, 2015

Study Start

June 1, 2014

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12