Clinical trial NCT02642133: Breastfeeding Improvement Following Tongue-tie and Lip-tie Release
Official title: Breastfeeding Improvement Following Tongue-tie and Lip-tie Release: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankyloglossia
Breastfeeding
Lead sponsor: The Oregon Clinic
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 237
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nipple Pain
timeFrame: 1 week
measure: Reflux/GERD
timeFrame: 1 week
measure: Breastfeeding efficiency
timeFrame: 1 week
measure: Breastfeeding self-efficacy
timeFrame: 1 week
Secondary outcomes:
measure: Nipple Pain
timeFrame: 1 month
measure: Reflux/GERD
timeFrame: 1 month
measure: Breastfeeding self-efficacy
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: The Oregon Clinic
name: Bobak A Ghaheri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.