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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 4 July 2017
Main ID:  ACTRN12617000897369
Date of registration: 19/06/2017
Prospective Registration: No
Primary sponsor: A/Prof Donna Geddes
Public title: Suck swallow breathe coordination in term breastfed infants with and without oral anomalies.
Scientific title: Infants with ankyloglossia and feeding difficulties: the effect of frenotomy on suck-swallow breathe coordination, intra-oral vacuum, breastfeeding efficiency and duration compared to age-matched infants without ankyloglossia and feeding difficulties.
Date of first enrolment: 15/08/2016
Target sample size: 60
Recruitment status: Recruiting
URL:  http://www.anzctr.org.au/ACTRN12617000897369.aspx
Study type:  Interventional
Study design:  Non-randomised trial  Parallel
Phase:  Not Applicable
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Health Condition(s) or Problem(s) studied
Ankyloglossia
Intervention(s)
Infants with ankyloglossia will attend one study session up to 10 days prior to frenotomy and one study session 14-21 days after frenotomy for monitoring of a breastfeed.
A paediatric surgeon will perform frenotomy, a simple surgical treatment that divides the lingual frenulum. Normally general anaesthesia is not required and some medical practitioners prefer to use a topical anaesthetic; the paediatric surgeon participating in this study does not use general anaesthesia in infants < 6 months (all of our study subjects are < 6 months of age and therefore will not have general anaesthesia). The infant’s tongue is gently lifted with a sterile grooved retractor or index finger to expose the lingual frenulum. An incision is made using sterile iris scissors to divide the frenulum between the tongue and alveolar ridge. The procedure is typically completed within a few minutes. The infant is immediately returned to the mother for a breastfeed.
All study infants will be followed up by telephone to 12 months of age.
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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