Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties

Tel-Aviv Sourasky Medical Center40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Breastfeeding

Interventions

Lingual Frenulum frenotomyPROCEDURE

Clipping the lingual frenulum with scissors

Sham frenotomyPROCEDURE

Sham Clipping the lingual frenulum with scissors

Eligibility

Sex: ALLMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * breastfeeding infants * maternal nipple pain * latching problems Exclusion Criteria: * oral cavity anomalies * breast anatomical anomalies * untreated tongue-tie in infant

Locations (1)

Tel Aviv Medical Center-Neonatology

Tel Aviv, Israel

Outcomes

Primary Outcomes

Pain score by Visual Analog Scale

Time frame: Within 30 minutes

Latch Score

Time frame: Within 30 Minutes

Data from ClinicalTrials.gov

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