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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective Group(Control) | Active Comparator |
| |
| Prospective Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Retrospective Group(Control) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | initial time of examination with study team, time of surgery (3 months post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Retrospective Group:
Unilateral cleft lip with or without cleft palate
Patients of a single surgeon (Matthew Greives, MD)
Patients with complete photographs:
Prospective Group:
Exclusion Criteria:
Retrospective Group:
Prospective Group:
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| Name | Affiliation | Role |
|---|---|---|
| Brett T Chiquet, DDS | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | pixels | initial time of examination with study team, time of surgery (3 months post intervention) |
|
4 months
Parents of patients in "treatment"/prospective arm could report challenges/pitfalls to investigator team, and investigator team met with family monthly (4 months, 20-30 minute appointments) to collect data and evaluate. Adverse event data were not collected for the retrospective arm, as IRB approval was not requested to contact retrospective participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett Chiquet, DDS, PhD, Associate Professor | The University of Texas Health Science Center at Houston | 7135008220 | Brett.T.Chiquet@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2020 | Mar 28, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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| Prospective Group | Device | 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. |
|
| initial time of examination with study team, time of surgery (3 months post intervention) |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Data for this measure were not collected. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
|
|
|
| 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. | Posted | Mean | Standard Deviation | degrees | initial time of examination with study team, time of surgery (3 months post intervention) |
|
|
|
|
| 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. | Data was not collected for this outcome measure. | Posted | initial time of examination with study team, time of surgery (3 months post intervention) |
|
|
| 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. | Data was not collected for this outcome measure. | Posted | initial time of examination with study team, time of surgery (3 months post intervention) |
|
|
| 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. | Data for this outcome measure were not collected from the retrospective arm, as IRB approval was not requested to contact retrospective participants. | Posted | Mean | Standard Deviation | number of responses | initial time of examination with study team, time of surgery (3 months post intervention) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Title | Measurements |
|---|---|
|