SuspendedNot Applicable

Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties

Stopped: Difficulty in recruiting participants

Israel40 participantsStarted 2009-10

Plain-language 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.

Who can participate

Age range6 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * breastfeeding infants * maternal nipple pain * latching problems Exclusion Criteria: * oral cavity anomalies * breast anatomical anomalies * untreated tongue-tie in infant

What they're measuring

Pain score by Visual Analog Scale

Timeframe: Within 30 minutes

Latch Score

Timeframe: Within 30 Minutes

Trial details

NCT IDNCT00970255

SponsorTel-Aviv Sourasky Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2015-10

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