Cleft Lip and Palate
Conditions
Keywords
Dynacleft
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.
Interventions
OTHERComparator: Retrospective Group(Control)
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.
DEVICEProspective Group
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | Columellar angle was measured from extraoral clinical photographs. Data reported is columellar angle at 3 months minus columellar angle at time of initial examination. |
| 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) | 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. |
| 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | initial time of examination with study team, time of surgery (3 months post intervention) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Retrospective Group(Control) Comparator: Retrospective Group(Control): 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. | 20 |
| Prospective Group Prospective Group: 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. | 4 |
| Total | 24 |
Baseline characteristics
| Characteristic | Retrospective Group(Control) | Prospective Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 4 Participants | 24 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 20 participants | 4 participants | 24 participants |
| Sex: Female, Male Female | — | — | 0 Participants |
| Sex: Female, Male Male | — | — | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 4 |
| other Total, other adverse events | 0 / 0 | 0 / 4 |
| serious Total, serious adverse events | 0 / 0 | 0 / 4 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retrospective Group(Control) | Changes in Soft Tissue as Indicated by Columellar Angle Measured From Extraoral Clinical Photographs | 54.93 degrees | Standard Deviation 5.124 |
| Prospective Group | Changes in Soft Tissue as Indicated by Columellar Angle Measured From Extraoral Clinical Photographs | 64.75 degrees | Standard Deviation 4.991 |
p-value: 0.00001t-test, 2 sided
Primary
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)
Population: Data was not collected for this outcome measure.
Primary
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)
Population: Data was not collected for this outcome measure.
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retrospective Group(Control) | Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs | 0.601 pixels | Standard Deviation 0.236 |
| Prospective Group | Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs | 0.435 pixels | Standard Deviation 0.111 |
p-value: 0.0088t-test, 2 sided
Secondary
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.
Time frame: initial time of examination with study team, time of surgery (3 months post intervention)
Population: Data for this outcome measure were not collected from the retrospective arm, as IRB approval was not requested to contact retrospective participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospective Group | 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 | improvement in quality of life | 2.27 number of responses | Standard Deviation 0.83 |
| Prospective Group | 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 | no change in quality of life | 1.68 number of responses | Standard Deviation 0.84 |
| Prospective Group | 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 | decrease in quality of life | 0 number of responses | Standard Deviation 0 |