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Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties

This study has suspended participant recruitment.
(Difficulty in recruiting participants)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970255
First Posted: September 2, 2009
Last Update Posted: August 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
  Purpose
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.

Condition Intervention
Breastfeeding Procedure: Lingual Frenulum frenotomy Procedure: Sham frenotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Labial Frenulum Clipping on Nipple Pain and Latch Problems in Breastfeeding Infants

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Pain score by Visual Analog Scale [ Time Frame: Within 30 minutes ]
  • Latch Score [ Time Frame: Within 30 Minutes ]

Estimated Enrollment: 40
Study Start Date: October 2009
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Frenotomy Procedure: Lingual Frenulum frenotomy
Clipping the lingual frenulum with scissors
Sham Comparator: Sham Frenotomy Procedure: Sham frenotomy
Sham Clipping the lingual frenulum with scissors

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • breastfeeding infants
  • maternal nipple pain
  • latching problems

Exclusion Criteria:

  • oral cavity anomalies
  • breast anatomical anomalies
  • untreated tongue-tie in infant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970255


Locations
Israel
Tel Aviv Medical Center-Neonatology
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00970255     History of Changes
Other Study ID Numbers: TASMC-08-SD-0559-CTIL
First Submitted: September 1, 2009
First Posted: September 2, 2009
Last Update Posted: August 2, 2012
Last Verified: August 2012

Keywords provided by Tel-Aviv Sourasky Medical Center:
Breastfeeding difficulties
lingual frenulum
labial frenulum
frenotomy