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

Primary Purpose

Cleft Lip and Palate

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comparator: Retrospective Group(Control)
Prospective Group
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Lip and Palate focused on measuring Dynacleft

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Retrospective Group(Control)

Prospective Group

Arm Description

Outcomes

Primary Outcome Measures

Changes in soft tissue as indicated by columellar angle measured from extraoral clinical photographs
Changes in soft tissue as indicated by nostril width measured from extraoral clinical photographs
Changes in soft tissue as indicated by nostril height measured from extraoral clinical photographs
Changes in soft tissue as indicated by width of the cleft lip measured from extraoral clinical photographs

Secondary Outcome Measures

Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire
Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire

Full Information

First Posted
June 26, 2020
Last Updated
November 4, 2020
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT04455035
Brief Title
DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants
Official Title
DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
Keywords
Dynacleft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retrospective Group(Control)
Arm Type
Active Comparator
Arm Title
Prospective Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Comparator: Retrospective Group(Control)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Prospective Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in soft tissue as indicated by columellar angle measured from extraoral clinical photographs
Time Frame
initial time of examination with study team, time of surgery(3 months post intervention)
Title
Changes in soft tissue as indicated by nostril width measured from extraoral clinical photographs
Time Frame
initial time of examination with study team, time of surgery(3 months post intervention)
Title
Changes in soft tissue as indicated by nostril height measured from extraoral clinical photographs
Time Frame
initial time of examination with study team, time of surgery(3 months post intervention)
Title
Changes in soft tissue as indicated by width of the cleft lip measured from extraoral clinical photographs
Time Frame
initial time of examination with study team, time of surgery(3 months post intervention)
Secondary Outcome Measure Information:
Title
Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire
Time Frame
initial time of examination with study team
Title
Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire
Time Frame
time of surgery(3 months post intervention)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahn Tran, DDS
Phone
(713) 486-4150
Email
Anh.T.Tran@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Audrena Hankins
Phone
(713) 486-2576
Email
Audrena.Hankins@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahn Tran, DDS
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anh Tran, DDs
Phone
713-486-4150
Email
Anh.T.Tran@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Audrena Hankins
Phone
(713) 486-2576
Email
Audrena.Hankins@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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