DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants

Study Overview
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Brief Summary
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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.

Official Title
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DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Other: Comparator: Retrospective Group(Control)
* Device: Prospective Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Retrospective Group: Unilateral cleft lip with or without cleft palate Patients of a single surgeon (Matthew Greives, MD) Patients with complete photographs: After birth, first visit At cleft lip repair (3-4 months) Post-operative cleft repair (about 1 year of age) Prospective Group: Patients with incomplete unilateral cleft lip with or without cleft palate Patients of any surgeon Exclusion Criteria: Retrospective Group: Bilateral cleft lip or complete unilateral cleft lip Patients operated on by other primary surgeons Patients with incomplete photo records will be evaluated to determine if the patient should be excluded Prospective Group: Patients with bilateral cleft lip or complete unilateral cleft lip Patients whose parents refuse to consent to inclusion Patients with tape allergies to the adhesive of the DynaCleft® Patients with syndromic craniofacial conditions or Tessier type facial clefts

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Retrospective Group(Control)<br> | Other: Comparator: Retrospective Group(Control)<br>* 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.<br>|
| Experimental: Prospective Group<br> | Device: Prospective Group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in soft tissue as indicated by columellar angle measured from extraoral clinical photographs |  | 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 |  | 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 |  | initial time of examination with study team, time of surgery(3 months post intervention) | 
| Changes in soft tissue as indicated by width of the cleft lip measured from extraoral clinical photographs |  | initial time of examination with study team, time of surgery(3 months post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire |  | initial time of examination with study team | 
| Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire |  | time of surgery(3 months post intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dynacleft