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Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties

NCT ID: NCT00970255

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Brief Summary

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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

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Conditions

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Breastfeeding

Keywords

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Breastfeeding difficulties lingual frenulum labial frenulum frenotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Frenotomy

Group Type ACTIVE_COMPARATOR

Lingual Frenulum frenotomy

Intervention Type PROCEDURE

Clipping the lingual frenulum with scissors

Sham Frenotomy

Group Type SHAM_COMPARATOR

Sham frenotomy

Intervention Type PROCEDURE

Sham Clipping the lingual frenulum with scissors

Interventions

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Lingual Frenulum frenotomy

Clipping the lingual frenulum with scissors

Intervention Type PROCEDURE

Sham frenotomy

Sham Clipping the lingual frenulum with scissors

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* breastfeeding infants
* maternal nipple pain
* latching problems

Exclusion Criteria

* oral cavity anomalies
* breast anatomical anomalies
* untreated tongue-tie in infant
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tel Aviv Medical Center-Neonatology

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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TASMC-08-SD-0559-CTIL

Identifier Type: -

Identifier Source: org_study_id