Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties

Tel Aviv Sourasky Medical Center

Status: Suspended

Conditions: Breastfeeding

Treatments: Procedure: Lingual Frenulum frenotomy; Procedure: Sham frenotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00970255

TASMC-08-SD-0559-CTIL

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• breastfeeding infants
• maternal nipple pain
• latching problems

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Frenotomy

Active Comparator group

Treatment:

Procedure: Lingual Frenulum frenotomy

Sham Frenotomy

Sham Comparator group

Treatment:

Procedure: Sham frenotomy