- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00967915
Efficacy of Neonatal Release of Ankyloglossia
August 27, 2009 updated by: United States Naval Medical Center, Portsmouth
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Virginia
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Portsmouth, Virginia, United States, 23708
- Naval Medical Center Portsmouth
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 weeks (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Frenotomy
Group of neonates that will receive frenotomy for tongue-tie
|
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_COMPARATOR: No frenotomy
Group of infants that will undergo sham procedure (no frenotomy performed)
|
Infant taken into room away from parents and no frenotomy performed.
Infant's mouth is examined but no interventions made.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
immediately following 1st breast feed, and at 2 week, 2,4,6 12 month follow ups
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of breast feeding
Time Frame: 1 year follow up
|
1 year follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (ACTUAL)
July 1, 2009
Study Registration Dates
First Submitted
August 27, 2009
First Submitted That Met QC Criteria
August 27, 2009
First Posted (ESTIMATE)
August 28, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 28, 2009
Last Update Submitted That Met QC Criteria
August 27, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007.0077
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankyloglossia
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Parc de Salut MarNot yet recruiting
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The Oregon ClinicCompletedBreastfeeding | Ankyloglossia
-
Yonsei UniversityCompleted
-
The Oregon ClinicCompletedBreastfeeding | Ankyloglossia
-
Parc de Salut MarCompleted
-
Universitat Internacional de CatalunyaCompleted
-
Princess Anna Mazowiecka Hospital, Warsaw, PolandMedical University of WarsawWithdrawnBreast Feeding, Exclusive | Ankyloglossia | Lactation Failure | Tongue-tiePoland
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Hvidovre University HospitalRecruiting
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University of South FloridaCompletedBreast Feeding | Ankyloglossia | Enlarged Labial FrenumUnited States
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University of OuluRecruitingBreast Feeding | Frenulum Breve | Tongue Tie | Frenulum; ElongationFinland