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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 1, 2009
Last Updated Date	August 1, 2012
Start Date ^ICMJE	October 2009
Estimated Primary Completion Date	October 2015 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 1, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00970255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties
Official Title ^ICMJE	Effect of Labial Frenulum Clipping on Nipple Pain and Latch Problems in Breastfeeding Infants
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Breastfeeding
Intervention ^ICMJE	Procedure: Lingual Frenulum frenotomy Clipping the lingual frenulum with scissors Procedure: Sham frenotomy Sham Clipping the lingual frenulum with scissors
Study Arm (s)	Active Comparator: Frenotomy Intervention: Procedure: Lingual Frenulum frenotomy Sham Comparator: Sham Frenotomy Intervention: Procedure: Sham frenotomy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Estimated Enrollment ^ICMJE	40
Completion Date	Not Provided
Estimated Primary Completion Date	October 2015 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: breastfeeding infants maternal nipple pain latching problems Exclusion Criteria: oral cavity anomalies breast anatomical anomalies untreated tongue-tie in infant
Gender	Both
Ages	up to 6 Months
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00970255
Other Study ID Numbers ^ICMJE	TASMC-08-SD-0559-CTIL
Has Data Monitoring Committee	No
Responsible Party	Tel-Aviv Sourasky Medical Center
Study Sponsor ^ICMJE	Tel-Aviv Sourasky Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Tel-Aviv Sourasky Medical Center
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top