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Efficacy of Neonatal Release of Ankyloglossia

NCT00967915 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-05-10

No results posted yet for this study

Summary

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.

Conditions

  • Ankyloglossia

Interventions

PROCEDURE

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.

OTHER

Sham procedure

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

Sponsors & Collaborators

  • United States Naval Medical Center, Portsmouth

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00967915 on ClinicalTrials.gov