The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.
The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip. DynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view. Linear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs
Width of the cleft lip was measured from extraoral clinical photographs. Data reported is width of cleft lip at 3 months minus width of cleft lip at time of initial examination.
Time frame: initial time of examination with study team, time of surgery (3 months post intervention)
Changes in Soft Tissue as Indicated by Columellar Angle Measured From Extraoral Clinical Photographs
Columellar angle was measured from extraoral clinical photographs. Data reported is columellar angle at 3 months minus columellar angle at time of initial examination.
Time frame: initial time of examination with study team, time of surgery (3 months post intervention)
Changes in Soft Tissue as Indicated by Nostril Height Measured From Extraoral Clinical Photographs
Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.
Time frame: initial time of examination with study team, time of surgery (3 months post intervention)
Changes in Soft Tissue as Indicated by Nostril Width Measured From Extraoral Clinical Photographs
Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.
Time frame: initial time of examination with study team, time of surgery (3 months post intervention)
Average Number of Responses Indicating Improvement, no Change, or Decrease in Quality of Life as Assessed by the Infant and New Parent Quality of Life Questionnaire
The Infant and New Parent Quality of Life questionnaire consists of 22 questions related to quality of life. For each question, it was determined whether the response at 3 months indicated an improvement, no change, or a decrease in quality of life relative to the response at the time of initial examination. The average number with an improvement in quality of life (averaged over all 22 questions), the average number who had no change in quality of life (averaged over all 22 questions), and the average number who had a decrease in quality of life (averaged over all 22 questions) are reported.
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Time frame: initial time of examination with study team, time of surgery (3 months post intervention)