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Efficacy of Neonatal Release of Ankyloglossia

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ClinicalTrials.gov Identifier: NCT00967915
Recruitment Status : Completed
First Posted : August 28, 2009
Last Update Posted : August 28, 2009
Sponsor:
Information provided by:
United States Naval Medical Center, Portsmouth

Tracking Information
First Submitted Date  ICMJE August 27, 2009
First Posted Date  ICMJE August 28, 2009
Last Update Posted Date August 28, 2009
Study Start Date  ICMJE November 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2009)
Maternal nipple pain as judged by R. Melzack's short form pain scale and infant breast feeding as judged by IBFAT scale [ Time Frame: immediately following 1st breast feed, and at 2 week, 2,4,6 12 month follow ups ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2009)
Length of breast feeding [ Time Frame: 1 year follow up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Neonatal Release of Ankyloglossia
Official Title  ICMJE Efficacy of Neonatal Release of Ankyloglossia
Brief Summary The purpose of this study is to determine if frenotomy for ankyloglossia will improve infant breastfeeding, decrease maternal nipple pain and increase duration of breastfeeding with the hypothesis that frenotomy will do all of the above.
Detailed Description The primary objective of our study is to determine if frenotomy (or release of tongue tie) for ankyloglossia (tongue tie) will decrease maternal nipple pain with breast feeding and improve infant's ability to breast feed. Our secondary objective is to determine if frenotomy for ankyloglossia will improve the length of time a mother breast feeds. Our hypothesis is that frenotomy will decrease maternal nipple pain, improve infant's breast feeding and prolong the duration of breast feeding.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Ankyloglossia
Intervention  ICMJE
  • Procedure: Frentomy
    Frenotomy will be performed. This procedure involves crushing frenulum tissue with straight hemostat for hemostasis and anesthesia while tongue is elevated with elevator. Frenulum then cut to desired length with iris scissors. Patient then returned to parents and immediately breastfeeds without parent observing infant's mouth.
  • Other: Sham procedure
    Infant taken into room away from parents and no frenotomy performed. Infant's mouth is examined but no interventions made.
Study Arms  ICMJE
  • Experimental: Frenotomy
    Group of neonates that will receive frenotomy for tongue-tie
    Intervention: Procedure: Frentomy
  • Sham Comparator: No frenotomy
    Group of infants that will undergo sham procedure (no frenotomy performed)
    Intervention: Other: Sham procedure
Publications * Buryk M, Bloom D, Shope T. Efficacy of neonatal release of ankyloglossia: a randomized trial. Pediatrics. 2011 Aug;128(2):280-8. doi: 10.1542/peds.2011-0077. Epub 2011 Jul 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2009)
58
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Significant ankyloglossia as judged by Hazelbaker scale (HATLFF)
  • Report of maternal nipple pain with feeding
  • Report of difficulty with infant breast feeding

Exclusion Criteria:

  • Significant craniofacial defects
  • Age >14 days at enrollment
  • Any maternal contraindication to breastfeeding
  • Neurologic defects that would impair breast feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 14 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00967915
Other Study ID Numbers  ICMJE 2007.0077
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE United States Naval Medical Center, Portsmouth
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account United States Naval Medical Center, Portsmouth
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP