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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frenotomy | Experimental | Group of neonates that will receive frenotomy for tongue-tie |
|
| No frenotomy | Sham Comparator | Group of infants that will undergo sham procedure (no frenotomy performed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frentomy | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of breast feeding | 1 year follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 23708 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21768318 | Derived | Buryk M, Bloom D, Shope T. Efficacy of neonatal release of ankyloglossia: a randomized trial. Pediatrics. 2011 Aug;128(2):280-8. doi: 10.1542/peds.2011-0077. Epub 2011 Jul 18. |
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| ID | Term |
|---|---|
| D000072676 | Ankyloglossia |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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|
| Sham procedure | Other | Infant taken into room away from parents and no frenotomy performed. Infant's mouth is examined but no interventions made. |
|