Clinical Trials Directory

Trials / Suspended

SuspendedNCT00970255

Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties

Effect of Labial Frenulum Clipping on Nipple Pain and Latch Problems in Breastfeeding Infants

Status
Suspended
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Tel-Aviv Sourasky Medical Center · Other Government
Sex
All
Age
6 Months
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELingual Frenulum frenotomyClipping the lingual frenulum with scissors
PROCEDURESham frenotomySham Clipping the lingual frenulum with scissors

Timeline

Start date
2009-10-01
Primary completion
2015-10-01
First posted
2009-09-02
Last updated
2012-08-02

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT00970255. Inclusion in this directory is not an endorsement.

Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties (NCT00970255) · Clinical Trials Directory