CompletedNot Applicable

Efficacy of Neonatal Release of Ankyloglossia

United States58 participantsStarted 2007-11

Plain-language 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.

Who can participate

Age range0 Days – 14 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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

Trial details

NCT IDNCT00967915

SponsorUnited States Naval Medical Center, Portsmouth

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2009-07

View on ClinicalTrials.gov More Ankyloglossia trials