Frenotomy of the Labial Frenulum in Infants With Breastfe... | NCT00970255

Studies
Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties

NCT00970255

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Suspended

Last Update Posted

Aug 2, 2012Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Breastfeeding

Interventions

Lingual Frenulum frenotomy
Sham frenotomy

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in recruiting participants

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Oct 2015Estimated

Completion Date

Not provided

First Submitted Date

Sep 1, 2009

First Submission Date that Met QC Criteria

Sep 1, 2009

First Posted Date

Sep 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2012

Last Update Posted Date

Aug 2, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Frenotomy	Active Comparator		Procedure: Lingual Frenulum frenotomy
Sham Frenotomy	Sham Comparator		Procedure: Sham frenotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lingual Frenulum frenotomy	Procedure	Clipping the lingual frenulum with scissors	Frenotomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score by Visual Analog Scale		Within 30 minutes
Latch Score		Within 30 Minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

breastfeeding infants
maternal nipple pain
latching problems

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel Aviv Medical Center-Neonatology		Tel Aviv		64239	Israel

ID	Term
D005247	Feeding Behavior
D001519	Behavior