Main
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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:
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ANZCTR |
Last refreshed on:
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4 July 2017 |
Main ID: |
ACTRN12617000897369 |
Date of registration:
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19/06/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Suck swallow breathe coordination in term breastfed infants with and without oral anomalies.
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Scientific title:
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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:
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15/08/2016 |
Target sample size:
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60 |
Recruitment status: |
Recruiting |
URL:
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http://www.anzctr.org.au/ACTRN12617000897369.aspx |
Study type:
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Interventional |
Study design:
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Non-randomised trial
Parallel |
Phase:
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Not Applicable
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Key inclusion & exclusion criteria
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Health Condition(s) or Problem(s) studied
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Ankyloglossia
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Intervention(s)
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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.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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