- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00970255
Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties
August 1, 2012 updated by: Tel-Aviv Sourasky Medical Center
Effect of Labial Frenulum Clipping on Nipple Pain and Latch Problems in Breastfeeding Infants
Upper lingual frenulum have been implicated as a cause for pain during breastfeeding and latch problems.
The investigators hypothesize that performing frenotomy of the frenulum may improve breastfeeding.
The investigators will include breastfeeding infants with pain or latch problems in whom the lingual frenulum had been treated but breastfeeding problems were not resolved.
The investigators plan to study the effect of frenotomy of the upper lingual frenulum on maternal pain (using pain score by visual analog scale) and/or latch score.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
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
-
-
-
Tel Aviv, Israel, 64239
- Tel Aviv Medical Center-Neonatology
-
-
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 6 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- breastfeeding infants
- maternal nipple pain
- latching problems
Exclusion Criteria:
- oral cavity anomalies
- breast anatomical anomalies
- untreated tongue-tie in infant
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: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Frenotomy
|
Clipping the lingual frenulum with scissors
|
Sham Comparator: Sham Frenotomy
|
Sham Clipping the lingual frenulum with scissors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain score by Visual Analog Scale
Time Frame: Within 30 minutes
|
Within 30 minutes
|
Latch Score
Time Frame: Within 30 Minutes
|
Within 30 Minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
October 1, 2009
Primary Completion (Anticipated)
October 1, 2015
Study Registration Dates
First Submitted
September 1, 2009
First Submitted That Met QC Criteria
September 1, 2009
First Posted (Estimate)
September 2, 2009
Study Record Updates
Last Update Posted (Estimate)
August 2, 2012
Last Update Submitted That Met QC Criteria
August 1, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- TASMC-08-SD-0559-CTIL
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.
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