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NCT00970255 Clinical Trial

Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties

Breastfeeding Clinical Trial

Official title:
Effect of Labial Frenulum Clipping on Nipple Pain and Latch Problems in Breastfeeding Infants

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00970255
Other study ID # TASMC-08-SD-0559-CTIL
Secondary ID
Status Suspended
Phase N/A
First received September 1, 2009
Last updated August 1, 2012
Start date October 2009

Study information
Verified date August 2012
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Suspended
Enrollment 40
Est. completion date
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 6 Months
Eligibility Inclusion Criteria:

- breastfeeding infants

- maternal nipple pain

- latching problems

Exclusion Criteria:

- oral cavity anomalies

- breast anatomical anomalies

- untreated tongue-tie in infant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Lingual Frenulum frenotomy
Clipping the lingual frenulum with scissors
• Sham frenotomy
Sham Clipping the lingual frenulum with scissors

Locations
Country Name City State
Israel Tel Aviv Medical Center-Neonatology Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain score by Visual Analog Scale Within 30 minutes No
Primary Latch Score Within 30 Minutes No
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