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OpenTrials
Completed

NCT Number: NCT00967915

Efficacy of Neonatal Release of Ankyloglossia

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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Key information

Conditions

Ankyloglossia Behavior Breast Feeding Feeding Behavior Stomatognathic Diseases

Age range

0 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sham Procedure

Other

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

Primary outcomes

  1. Maternal nipple pain as judged by R. Melzack's short form pain scale and infant breast feeding as judged by IBFAT scale

    Time frame: immediately following 1st breast feed, and at 2 week, 2,4,6 12 month follow ups

Secondary outcomes

  1. Length of breast feeding

    Time frame: 1 year follow up

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, Portsmouth

Fed

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 28, 2009
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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