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Efficacy of Neonatal Release of Ankyloglossia

Efficacy of Neonatal Release of Ankyloglossia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00967915
Enrollment
58
Registered
2009-08-28
Start date
2007-11-30
Completion date
2009-07-31
Last updated
2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankyloglossia

Keywords

Ankyloglossia, Tongue tie, Frenotomy, Frenulectomy, Breast feeding, HATLFF, IBFAT

Brief 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.

Detailed description

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.

Interventions

PROCEDUREFrentomy

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.

OTHERSham procedure

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

Sponsors

United States Naval Medical Center, Portsmouth
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
0 Days to 14 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Maternal nipple pain as judged by R. Melzack's short form pain scale and infant breast feeding as judged by IBFAT scaleimmediately following 1st breast feed, and at 2 week, 2,4,6 12 month follow ups

Secondary

MeasureTime frame
Length of breast feeding1 year follow up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026