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Completed

NCT Number: NCT02642133

Breastfeeding Improvement Following Tongue-tie and Lip-tie Release

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.

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Key information

Conditions

Ankyloglossia Behavior Breast Feeding Breastfeeding Feeding Behavior Stomatognathic Diseases

Age range

1 day–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Breastfeeding rates in the United States initiate at around 80%, but many mothers are unable to effectively breastfeeding because of problems with latch and suction generation. Previous studies have demonstrated how nipple pain is directly linked to ankyloglossia, but most of these studies are done with poor methodology.

Clinically, tongue-tie and lip-tie have correlate with numerous other symptoms besides nipple pain. These babies tend to be inefficient nursers, which can affect weight gain. Abnormal intake of air because of the poor latch/seal can lead to reflux symptoms. Finally, there is a significant psychological toll on mothers who want to breastfeed but cannot do so.

This study aims to prospectively analyze these outcomes by using validated tools.

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 0-12 weeks of age

Exclusion criteria

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

Treatment and study plan

Lingual frenotomy and/or maxillary labial frenectomy

Procedure

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.

Primary outcomes

  1. Nipple Pain

    Time frame: 1 week

    Using a visual analog scale, nipple pain is evaluated.

  2. Reflux/GERD

    Time frame: 1 week

    Using a validated questionnaire (i-GERQ-R)

  3. Breastfeeding efficiency

    Time frame: 1 week

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

  4. Breastfeeding self-efficacy

    Time frame: 1 week

    Uses the BSES-SF validated questionnaire

Secondary outcomes

  1. Nipple Pain

    Time frame: 1 month

    Using a visual analog scale, nipple pain is evaluated.

  2. Reflux/GERD

    Time frame: 1 month

    Using a validated questionnaire (i-GERQ-R)

  3. Breastfeeding self-efficacy

    Time frame: 1 month

    Uses the BSES-SF validated questionnaire

Sponsors and collaborators

Lead sponsor

The Oregon Clinic

Other

Registry information

Official study title

Breastfeeding Improvement Following Tongue-tie and Lip-tie Release: A Prospective Cohort Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 30, 2015
Registry last updated
Dec 30, 2015

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.

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