Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties

Not Applicable

Suspended

• Conditions: Breastfeeding
• Interventions: Procedure: Lingual Frenulum frenotomy; Procedure: Sham frenotomy

• Registration Number: NCT00970255
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Study Start: 2009-10
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02
• Primary Completion: 2015-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• breastfeeding infants
• maternal nipple pain
• latching problems

Exclusion Criteria

• oral cavity anomalies
• breast anatomical anomalies
• untreated tongue-tie in infant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Frenotomy	Lingual Frenulum frenotomy	-
Sham Frenotomy	Sham frenotomy	-

Primary Outcome Measures

Name	Time	Method
Pain score by Visual Analog Scale	Within 30 minutes
Latch Score	Within 30 Minutes

Trial Locations

Locations (1)

Tel Aviv Medical Center-Neonatology; 🇮🇱 Tel Aviv, Israel