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Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties

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ClinicalTrials.gov Identifier: NCT00970255
Recruitment Status : Suspended (Difficulty in recruiting participants)
First Posted : September 2, 2009
Last Update Posted : August 2, 2012
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:
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 or disease Intervention/treatment
Breastfeeding Procedure: Lingual Frenulum frenotomy Procedure: Sham frenotomy

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : October 2009
Estimated Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Arm Intervention/treatment
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



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


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

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

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00970255     History of Changes
Other Study ID Numbers: TASMC-08-SD-0559-CTIL
First Posted: September 2, 2009    Key Record Dates
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