Efficacy of Neonatal Release of Ankyloglossia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-07-31

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.

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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.

Conditions

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Ankyloglossia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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Frenotomy

Group of neonates that will receive frenotomy for tongue-tie

Group Type EXPERIMENTAL

Frentomy

Intervention Type 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.

No frenotomy

Group of infants that will undergo sham procedure (no frenotomy performed)

Group Type SHAM_COMPARATOR

Sham procedure

Intervention Type OTHER

Infant taken into room away from parents and no frenotomy performed. Infant's mouth is examined but no interventions made.

Interventions

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Frentomy

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.

Intervention Type PROCEDURE

Sham procedure

Infant taken into room away from parents and no frenotomy performed. Infant's mouth is examined but no interventions made.

Intervention Type OTHER

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

Minimum Eligible Age

0 Days

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes