Study Stopped
Difficulty in recruiting participants
Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties
Effect of Labial Frenulum Clipping on Nipple Pain and Latch Problems in Breastfeeding Infants
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2009
CompletedFirst Posted
Study publicly available on registry
September 2, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedAugust 2, 2012
August 1, 2012
6 years
September 1, 2009
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pain score by Visual Analog Scale
Within 30 minutes
Latch Score
Within 30 Minutes
Study Arms (2)
Frenotomy
ACTIVE COMPARATORSham Frenotomy
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- breastfeeding infants
- maternal nipple pain
- latching problems
You may not qualify if:
- oral cavity anomalies
- breast anatomical anomalies
- untreated tongue-tie in infant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tel Aviv Medical Center-Neonatology
Tel Aviv, 64239, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2009
First Posted
September 2, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2015
Last Updated
August 2, 2012
Record last verified: 2012-08