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| Name | Class |
|---|---|
| The Emmes Company, LLC | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
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The purpose of this study is to assess the safety and efficacy of Timolol 0.25% and 0.5% doses.
Primary: Describe the efficacy of 0.25% and 0.5% topical timolol maleate Gel-forming solution (GFS) as assessed through Infantile Hemangioma (IH) changes in volume.
Secondary: Describe the safety of topical timolol maleate GFS for treatment of IH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.25% Timolol Treatment | Experimental | Subjects assigned to this arm will be randomized to 0.25% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.25% timolol they will be changed to 0.5% timolol. |
|
| 0.5% Timolol Treatment | Experimental | Subjects assigned to this arm will be randomized to 0.5% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.5% timolol the treating physician will decide to either continue 0.5% timolol or withdraw the subject and begin an alternative treatment. |
|
| Non-Intervention Group | No Intervention | Subjects assigned to this group will not receive treatment. The subject will only be photographed on the same schedule as the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.25% Timolol Maleate Gel Forming Solution | Drug | 50:50 Randomized 0.25% Timolol Maleate Gel Forming Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | The VAS-volume is a 100 mm scale used to independently grade hemangioma volume. -100 indicates hemangioma has doubled in size, 0 indicates no change, and +100 indicates complete shrinkage. Partial response is defined as >20% and up to 80% reduction in volumetric size of hemangioma. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Partial Response in Hemangioma Color as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | The VAS-color is a 100 mm scale used to independently grade hemangioma color. -100 indicates hemangioma is twice as intense, 0 indicates no change, and +100 indicates complete resolution. Partial response is defined as >30% and up to 80% reduction in color of hemangioma. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) Analysis Measuring Maximum Concentration of Timolol in Plasma Specimen | The PK blood samples will be 1.0 ml each and collected between the following timeframes after application of Timolol: within 2 hours, 2-4 hours, 5-7 hours, 8-10 hours or 11-12 hours. | Up to 12 hours |
| Pharmacokinetics (PK) Analysis Measuring Area Under the Curve of Timolol in Plasma Specimen |
Inclusion Criteria
Documented informed consent from legal guardian
0-84 days postnatal age at time of first study dose or when enrolled into the non-intervention cohort.
Clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must include all of the following):
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kanecia Zimmerman, MD, MHS | Duke Clinical Research Institute | Principal Investigator |
| Kristin Holland, MD | Medical College of Wisconsin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States | ||
| Indiana University Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30790601 | Background | Drolet BA, Boakye-Agyeman F, Harper B, Holland K, Lewandowski A, Stefanko N, Melloni C; Pediatric Trials Network Steering Committee (See Acknowledgments for a listing of committee members.). Systemic timolol exposure following topical application to infantile hemangiomas. J Am Acad Dermatol. 2020 Mar;82(3):733-736. doi: 10.1016/j.jaad.2019.02.029. Epub 2019 Feb 18. No abstract available. |
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Infants who were eligible for the study based on inclusion and exclusion criteria but whose parents declined treatment of the hemangioma constituted the non-intervention arm of the study and served as a control group
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.25% Timolol Treatment | Subjects assigned to this arm will be randomized to 0.25% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.25% timolol they will be changed to 0.5% timolol. 0.25% Timolol Maleate Gel Forming Solution: 50:50 Randomized 0.25% Timolol Maleate Gel Forming Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Nov 19, 2021 |
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| 0.5% Timolol Maleate Gel Forming Solution | Drug | 50:50 Randomized 0.5% Timolol Maleate Gel Forming Solution |
|
| 180 days |
| Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm | The VAS-volume is a 100 mm scale used to independently grade hemangioma volume. -100 indicates hemangioma has doubled in size, 0 indicates no change, and +100 indicates complete shrinkage. Partial response is defined as >20% and up to 80% reduction in volumetric size of hemangioma. | 180 days |
| Comparison of Partial Response of Hemangioma Color From Baseline to 180 Days, Within Each Treatment Arm | Comparison of partial response of hemangioma color (partial response or greater as assessed by VAS-color) between the two treatment arms. Partial response: >30% and up to 80% reduction in color of hemangioma. | 180 days |
| Change in Hemangioma Dynamic Complication Scale (HDCS) | Absolute change in hemangioma dynamic complication scale from Day 0 to end of study within each treatment arm. The HDCS provides a 6-point severity grading system for 12 individual hemangioma-related complications (grade 0 represents absent to minimal; grade 5 = most severe). The total score ranges from 0-60. | baseline, day 180 |
| Number of Participants Who Reach Partial Response, Assessed by Volume | Assess time to partial response or greater by VAS-volume, comparing baseline to day 30, day 60, day 120 and day 180. Partial response: >20% and up to 80% reduction in volumetric size of hemangioma | 30 days, 60 days, 120 days, 180 days |
| Number of Participants Who Reach Partial Response, Assessed by Hemangioma Color | Assess time to partial response or greater by VAS-color, comparing baseline to day 30, day 60, day 120 and day 180. Partial response: >30% and up to 80% reduction in color of hemangioma | 180 days |
| Change in Hemangioma Quality of Life (IH-QoL) Assessment for Infants | Absolute change in IH-QoL score scale from Day 0 to end of study within each treatment arm. The IH-QoL score scale consists of 4 domains (physical symptom of patient, social functioning of patient, social and psychological functioning of caregiver, and emotional functioning of caregiver) and 29 items, with each item scored on a Likert scale : 0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem and 4 = almost always a problem). The total range is 0-116; the higher the total number indicates a worse outcome. | baseline, day 180 |
| Number of Serious Adverse Events and Adverse Events of Special Interest in Infants Treated With Topical Timolol Maleate | Serious adverse events and adverse events of special interest from randomization to Day 180 in infants treated with topical timolol maleate (0.25% and 0.5%) GFS for the treatment of infantile hemangioma. | up to 270 days |
The PK blood samples will be 1.0 ml each and collected between the following timeframes after application of Timolol: within 2 hours, 2-4 hours, 5-7 hours, 8-10 hours or 11-12 hours. |
| Up to 12 hours |
| Pharmacokinetics (PK) Analysis Measuring Volume of Distribution of Timolol in Plasma Specimen | The PK blood samples will be 1.0 ml each and collected between the following timeframes after application of Timolol: within 2 hours, 2-4 hours, 5-7 hours, 8-10 hours or 11-12 hours. | Up to 12 hours |
| Pharmacokinetics (PK) Analysis Measuring Clearance of Timolol in Plasma Specimen | The PK blood samples will be 1.0 ml each and collected between the following timeframes after application of Timolol: within 2 hours, 2-4 hours, 5-7 hours, 8-10 hours or 11-12 hours. | Up to 12 hours |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Johns Hopkins Medical Center | Baltimore | Maryland | 21287 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadephia | Philadelphia | Pennsylvania | 19104 | United States |
| The University of Texas Medical School at Houston | Houston | Texas | 77030 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| FG001 | 0.5% Timolol Treatment | Subjects assigned to this arm will be randomized to 0.5% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.5% timolol the treating physician will decide to either continue 0.5% timolol or withdraw the subject and begin an alternative treatment. 0.5% Timolol Maleate Gel Forming Solution: 50:50 Randomized 0.5% Timolol Maleate Gel Forming Solution |
| FG002 | Non-Intervention Group | Subjects assigned to this group will not receive treatment. The subject will only be photographed on the same schedule as the intervention group. |
| FG003 | Historical Controls | To obtain sufficient age-matched controls, data and clinical photographs collected as part of a similar study (EudraCT 2013-005199-17) were included in the analysis of certain outcome measures as noted in the Analysis Population Description of those measures. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.25% Timolol Treatment | Subjects assigned to this arm will be randomized to 0.25% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.25% timolol they will be changed to 0.5% timolol. 0.25% Timolol Maleate Gel Forming Solution: 50:50 Randomized 0.25% Timolol Maleate Gel Forming Solution |
| BG001 | 0.5% Timolol Treatment | Subjects assigned to this arm will be randomized to 0.5% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.5% timolol the treating physician will decide to either continue 0.5% timolol or withdraw the subject and begin an alternative treatment. 0.5% Timolol Maleate Gel Forming Solution: 50:50 Randomized 0.5% Timolol Maleate Gel Forming Solution |
| BG002 | Non-Intervention Group | Subjects assigned to this group will not receive treatment. The subject will only be photographed on the same schedule as the intervention group. |
| BG003 | Historical Control Group | To obtain sufficient age-matched controls, data and clinical photographs collected as part of a similar study (EudraCT 2013-005199-17) were included in the analysis of certain outcome measures as noted in the Analysis Population Description of those measures. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | The VAS-volume is a 100 mm scale used to independently grade hemangioma volume. -100 indicates hemangioma has doubled in size, 0 indicates no change, and +100 indicates complete shrinkage. Partial response is defined as >20% and up to 80% reduction in volumetric size of hemangioma. | The Historical Control group was included with the Non-intervention group. Excludes 8 participants (four in the 0.5% dosage and four in the historical placebo controls) with out come determined to be unevaluable as they have no reported VAS scores | Posted | Count of Participants | Participants | 180 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Partial Response in Hemangioma Color as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | The VAS-color is a 100 mm scale used to independently grade hemangioma color. -100 indicates hemangioma is twice as intense, 0 indicates no change, and +100 indicates complete resolution. Partial response is defined as >30% and up to 80% reduction in color of hemangioma. | The Historical Control group was included with the Non-intervention group. Only participants with evaluable data were included in the analysis. | Posted | Count of Participants | Participants | 180 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm | The VAS-volume is a 100 mm scale used to independently grade hemangioma volume. -100 indicates hemangioma has doubled in size, 0 indicates no change, and +100 indicates complete shrinkage. Partial response is defined as >20% and up to 80% reduction in volumetric size of hemangioma. | Only participants with evaluable data were included in the analysis. | Posted | Count of Participants | Participants | 180 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of Partial Response of Hemangioma Color From Baseline to 180 Days, Within Each Treatment Arm | Comparison of partial response of hemangioma color (partial response or greater as assessed by VAS-color) between the two treatment arms. Partial response: >30% and up to 80% reduction in color of hemangioma. | Only participants with evaluable data were included in the analysis. | Posted | Count of Participants | Participants | 180 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Hemangioma Dynamic Complication Scale (HDCS) | Absolute change in hemangioma dynamic complication scale from Day 0 to end of study within each treatment arm. The HDCS provides a 6-point severity grading system for 12 individual hemangioma-related complications (grade 0 represents absent to minimal; grade 5 = most severe). The total score ranges from 0-60. | Only participants with evaluable data were included in the analysis. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, day 180 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Reach Partial Response, Assessed by Volume | Assess time to partial response or greater by VAS-volume, comparing baseline to day 30, day 60, day 120 and day 180. Partial response: >20% and up to 80% reduction in volumetric size of hemangioma | Only participants with evaluable data were included in the analysis. | Posted | Count of Participants | Participants | 30 days, 60 days, 120 days, 180 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Reach Partial Response, Assessed by Hemangioma Color | Assess time to partial response or greater by VAS-color, comparing baseline to day 30, day 60, day 120 and day 180. Partial response: >30% and up to 80% reduction in color of hemangioma | Only participants with evaluable data were included in the analysis. | Posted | Count of Participants | Participants | 180 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Hemangioma Quality of Life (IH-QoL) Assessment for Infants | Absolute change in IH-QoL score scale from Day 0 to end of study within each treatment arm. The IH-QoL score scale consists of 4 domains (physical symptom of patient, social functioning of patient, social and psychological functioning of caregiver, and emotional functioning of caregiver) and 29 items, with each item scored on a Likert scale : 0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem and 4 = almost always a problem). The total range is 0-116; the higher the total number indicates a worse outcome. | Only participants with evaluable data were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline, day 180 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Serious Adverse Events and Adverse Events of Special Interest in Infants Treated With Topical Timolol Maleate | Serious adverse events and adverse events of special interest from randomization to Day 180 in infants treated with topical timolol maleate (0.25% and 0.5%) GFS for the treatment of infantile hemangioma. | Only participants who received treatment and had evaluable data were included in this analysis | Posted | Number | adverse events | up to 270 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Pharmacokinetics (PK) Analysis Measuring Maximum Concentration of Timolol in Plasma Specimen | The PK blood samples will be 1.0 ml each and collected between the following timeframes after application of Timolol: within 2 hours, 2-4 hours, 5-7 hours, 8-10 hours or 11-12 hours. | Not Posted | Up to 12 hours | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Pharmacokinetics (PK) Analysis Measuring Area Under the Curve of Timolol in Plasma Specimen | The PK blood samples will be 1.0 ml each and collected between the following timeframes after application of Timolol: within 2 hours, 2-4 hours, 5-7 hours, 8-10 hours or 11-12 hours. | Not Posted | Up to 12 hours | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Pharmacokinetics (PK) Analysis Measuring Volume of Distribution of Timolol in Plasma Specimen | The PK blood samples will be 1.0 ml each and collected between the following timeframes after application of Timolol: within 2 hours, 2-4 hours, 5-7 hours, 8-10 hours or 11-12 hours. | Not Posted | Up to 12 hours | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Pharmacokinetics (PK) Analysis Measuring Clearance of Timolol in Plasma Specimen | The PK blood samples will be 1.0 ml each and collected between the following timeframes after application of Timolol: within 2 hours, 2-4 hours, 5-7 hours, 8-10 hours or 11-12 hours. | Not Posted | Up to 12 hours | Participants |
Any event excluding adverse events of special interest beginning more than 7 days after the last dose of study drug or last study procedure will not be reported. For participants in the treatment arm adverse events of special interest only will be reviewed and reported at 90 days after the last dose of study drug.
0 participants in the historical control arm were at risk for Adverse Events because they did not prospectively participate in this research study. Only data that had already been collected was used in this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.25% Timolol Treatment | Subjects assigned to this arm will be randomized to 0.25% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.25% timolol they will be changed to 0.5% timolol. 0.25% Timolol Maleate Gel Forming Solution: 50:50 Randomized 0.25% Timolol Maleate Gel Forming Solution | 0 | 44 | 3 | 44 | 31 | 44 |
| EG001 | 0.5% Timolol Treatment | Subjects assigned to this arm will be randomized to 0.5% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.5% timolol the treating physician will decide to either continue 0.5% timolol or withdraw the subject and begin an alternative treatment. 0.5% Timolol Maleate Gel Forming Solution: 50:50 Randomized 0.5% Timolol Maleate Gel Forming Solution | 0 | 51 | 2 | 51 | 28 | 51 |
| EG002 | Non-Intervention Group | Subjects assigned to this group will not receive treatment. The subject will only be photographed on the same schedule as the intervention group. | 0 | 10 | 0 | 10 | 4 | 10 |
| EG003 | Historical Controls | To obtain sufficient age-matched controls, data and clinical photographs collected as part of a similar study (EudraCT 2013-005199-17) were included in the analysis of certain outcome measures as noted in the Analysis Population Description of those measures. | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Influenza | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory syncytial virus bronchiolitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dacryostenosis congenital | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Plagiocephaly | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Amblyopia | Eye disorders | Systematic Assessment |
| ||
| Eye discharge | Eye disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | General disorders | Systematic Assessment |
| ||
| Inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Teething | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Vaccination site pain | General disorders | Systematic Assessment |
| ||
| Acute sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Bronchiolitis | Infections and infestations | Systematic Assessment |
| ||
| Candida nappy rash | Infections and infestations | Systematic Assessment |
| ||
| Conjunctivitis | Infections and infestations | Systematic Assessment |
| ||
| Conjunctivitis bacterial | Infections and infestations | Systematic Assessment |
| ||
| Coxsackie viral infection | Infections and infestations | Systematic Assessment |
| ||
| Croup infectious | Infections and infestations | Systematic Assessment |
| ||
| Ear infection | Infections and infestations | Systematic Assessment |
| ||
| Eye infection | Infections and infestations | Systematic Assessment |
| ||
| Hand-foot-and-mouth disease | Infections and infestations | Systematic Assessment |
| ||
| Herpangina | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Oral candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Otitis media acute | Infections and infestations | Systematic Assessment |
| ||
| Otitis media chronic | Infections and infestations | Systematic Assessment |
| ||
| Respiratory syncytial virus bronchiolitis | Infections and infestations | Systematic Assessment |
| ||
| Respiratory syncytial virus infection | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection viral | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Viral rash | Infections and infestations | Systematic Assessment |
| ||
| Head injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Scar | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Crystal urine present | Investigations | Systematic Assessment |
| ||
| Dairy intolerance | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Failure to thrive | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Hypotonia | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Irritability | Psychiatric disorders | Systematic Assessment |
| ||
| Mental status changes | Psychiatric disorders | Systematic Assessment |
| ||
| Sleep disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Apnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cyanosis central | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dermatitis atopic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis diaper | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Milia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Peripheral coldness | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kanecia Zimmerman, MD, PhD, MPH | Duke Clinical Research Institute | 919-668-8651 | kanecia.zimmerman@duke.edu |
| Oct 17, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D018324 | Hemangioma, Capillary |
| D006391 | Hemangioma |
| ID | Term |
|---|---|
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Odds Ratio, log |
| 2.16 |
| 2-Sided |
| 95 |
| 0.91 |
| 5.14 |
| Superiority |
| Fisher Exact | 0.6281 | Odds Ratio, log | 1.23 | 2-Sided | 95 | 0.53 | 2.82 | Superiority |
| OG002 | Non-Intervention Group | Subjects assigned to this group will not receive treatment. The subject will only be photographed on the same schedule as the intervention group. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 | Non-Intervention Group | Subjects assigned to this group will not receive treatment. The subject will only be photographed on the same schedule as the intervention group. |
|
|
| Non-Intervention Group |
Subjects assigned to this group will not receive treatment. The subject will only be photographed on the same schedule as the intervention group. |
|
|
Subjects assigned to this group will not receive treatment. The subject will only be photographed on the same schedule as the intervention group. |
|
|
| OG002 | Non-Intervention Group | Subjects assigned to this group will not receive treatment. The subject will only be photographed on the same schedule as the intervention group. |
|
|
| OG002 |
| Non-Intervention Group |
Subjects assigned to this group will not receive treatment. The subject will only be photographed on the same schedule as the intervention group. |
|
|