Efficacy of Neonatal Release of Ankyloglossia

Study Overview
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Brief Summary
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The purpose of this study is to determine if frenotomy for ankyloglossia will improve infant breastfeeding, decrease maternal nipple pain and increase duration of breastfeeding with the hypothesis that frenotomy will do all of the above.

Detailed Description
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The primary objective of our study is to determine if frenotomy (or release of tongue tie) for ankyloglossia (tongue tie) will decrease maternal nipple pain with breast feeding and improve infant's ability to breast feed. Our secondary objective is to determine if frenotomy for ankyloglossia will improve the length of time a mother breast feeds. Our hypothesis is that frenotomy will decrease maternal nipple pain, improve infant's breast feeding and prolong the duration of breast feeding.

Official Title
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Efficacy of Neonatal Release of Ankyloglossia

Conditions
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Ankyloglossia

Intervention / Treatment
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* Procedure: Frentomy
* Other: Sham procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Significant ankyloglossia as judged by Hazelbaker scale (HATLFF) Report of maternal nipple pain with feeding Report of difficulty with infant breast feeding Exclusion Criteria: Significant craniofacial defects Age >14 days at enrollment Any maternal contraindication to breastfeeding Neurologic defects that would impair breast feeding

Ages Eligible for Study
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Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Frenotomy<br>Group of neonates that will receive frenotomy for tongue-tie | Procedure: Frentomy<br>* Frenotomy will be performed. This procedure involves crushing frenulum tissue with straight hemostat for hemostasis and anesthesia while tongue is elevated with elevator. Frenulum then cut to desired length with iris scissors. Patient then returned to parents and immediately breastfeeds without parent observing infant's mouth.<br>|
| Sham Comparator: No frenotomy<br>Group of infants that will undergo sham procedure (no frenotomy performed) | Other: Sham procedure<br>* Infant taken into room away from parents and no frenotomy performed. Infant's mouth is examined but no interventions made.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal nipple pain as judged by R. Melzack's short form pain scale and infant breast feeding as judged by IBFAT scale |  | immediately following 1st breast feed, and at 2 week, 2,4,6 12 month follow ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of breast feeding |  | 1 year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankyloglossia, Tongue tie, Frenotomy, Frenulectomy, Breast feeding, HATLFF, IBFAT