Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties

This study has suspended participant recruitment.
(Difficulty in recruiting participants)
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00970255
First received: September 1, 2009
Last updated: August 1, 2012
Last verified: August 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
  • Latch Score [ Time Frame: Within 30 Minutes ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970255

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

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00970255     History of Changes
Other Study ID Numbers: TASMC-08-SD-0559-CTIL
Study First Received: September 1, 2009
Last Updated: August 1, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on April 22, 2014