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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL068270 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure.
This is a non-randomized pilot study to evaluate the safety and feasibility of an exercise program in hospitalized infants with single ventricle physiology. Following the Norwood procedure, the intervention will be administered for up to 21 days or until discharge, whichever comes first. Data will be collected daily during hospitalization and at a follow-up visit at 3 months of age. Sources of data will include medical record review. Twenty subjects will be enrolled at three Pediatric Heart Network study sites (Utah Primary Children's Hospital, Children's Hospital of Philadelphia and Texas Children's Hospital). Subjects will be recruited following Institutional Review Board (IRB) approval at each institution and parental/legal guardian consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passive range of motion (ROM) exercise | Experimental | A 10 - 15 minute passive range of motion (ROM) exercise program will be administered daily during hospitalization for up to 21 days or until discharge (whichever comes first). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passive range of motion (ROM) exercise | Other | After their Norwood surgery, stable subjects will undergo passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever comes first. Subjects will have completed the study after their anthropometric measurements are collected at 3 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) and Serious Adverse Events (SAEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology |
| during the intervention and for one hour afterwards, daily up to 21 days |
| Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology | Percentage of days with high completion, medium completion, and low completion of the intervention:
Percentage of days with high/medium/low completion was then calculated across all participants and days | during intervention, up to 21 days |
| Number of Participants With Adverse Events (AEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology | • Number of participants with adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded | during the intervention and for one hour afterwards, daily up to 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Lambert, MSN, c-FNP | Utah Primary Children's Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States | ||
| Baylor College of Medicine - Texas Children's Hospital |
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| Label | URL |
|---|---|
| Pediatric Heart Network | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Passive Range of Motion (ROM) Exercise | A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first). Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Passive Range of Motion (ROM) Exercise | A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first). Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Adverse Events (AEs) and Serious Adverse Events (SAEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology |
| Posted | Number | events | during the intervention and for one hour afterwards, daily up to 21 days |
|
through final (pre-Stage II palliation) study visit, which occurred at a different age and time from initial surgery for each participant, typically at 3-6 months of age
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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 | Passive Range of Motion (ROM) Exercise | A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first). Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac arrest | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intermittent Sinus Tachycardia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Felicia Trachtenberg | New England Research Institutes | 617-972-3120 | FTrachtenberg@neriscience.com |
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| ID | Term |
|---|---|
| D000080039 | Univentricular Heart |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D016059 | Range of Motion, Articular |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
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|
| Houston |
| Texas |
| 77030 |
| United States |
| Utah Primary Children's Medical Center | Salt Lake City | Utah | 84132 | United States |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology | Percentage of days with high completion, medium completion, and low completion of the intervention:
Percentage of days with high/medium/low completion was then calculated across all participants and days | Posted | Number | percent of days | during intervention, up to 21 days |
|
|
|
| Primary | Number of Participants With Adverse Events (AEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology | • Number of participants with adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded | Posted | Number | participants | during the intervention and for one hour afterwards, daily up to 21 days |
|
|
|
| 1 |
| 20 |
| 3 |
| 20 |
| 5 |
| 20 |
| hypercarbia secondary to oversedation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| laryngomalacia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| respiratory distress with hypercapnia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Poor weight gain | General disorders | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Tachypnic with feeds | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| increased work of breathing with feeds | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| midsternal wound dehiscence | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| ventricular bigeminy | Cardiac disorders | Systematic Assessment |
|
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009043 | Motor Activity |
| D009068 | Movement |
| Title | Measurements |
|---|---|
|