Ankyloglossia, Breastfeeding
Conditions
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.
Detailed description
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.
Interventions
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.
Sponsors
The Oregon Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nipple Pain | 1 week | Using a visual analog scale, nipple pain is evaluated. |
| Reflux/GERD | 1 week | Using a validated questionnaire (i-GERQ-R) |
| Breastfeeding efficiency | 1 week | Volume of breastmilk ingested in a specific time frame calculated (mL/min) |
| Breastfeeding self-efficacy | 1 week | Uses the BSES-SF validated questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reflux/GERD | 1 month | Using a validated questionnaire (i-GERQ-R) |
| Breastfeeding self-efficacy | 1 month | Uses the BSES-SF validated questionnaire |
| Nipple Pain | 1 month | Using a visual analog scale, nipple pain is evaluated. |
Outcome results
None listed