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The objectives of this pilot study are to evaluate the feasibility and safety of intramyocardial injection of autologous c-kit+ cells during the Stage II Bidirectional Cavopulmonary Anastomosis (BDCPA) operation and to observe effects on clinical outcome including right ventricular myocardial function, severity of tricuspid regurgitation, incidence of serious adverse events, re-hospitalizations, changes in health status, the need for transplantation, or mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label C-kit+ cells Group A | Experimental | Group A is an open-label treatment group determining safety and feasibility. Participants enrolled in this group will be receiving previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially. |
|
| C-kit+ cells Group B | Active Comparator | Participants randomized to Group B Treatment Group will receive previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially. |
|
| No Intervention Group | No Intervention | Participants randomized to Group B Control Group will receive only their standard of care (SOC) Stage II BDCPA operation without the injection of harvested c-kit+ cells. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| c-kit+ cells | Biological | The autologous c-kit+ cells will be harvested from participant's right atrial tissue obtained from participant's SOC Norwood Operation. The harvested c-kit+ cells containing up to a total of 12,500 cells/kg will be delivered through 6-10 intramyocardial injections of approximately 100uL per injection for a total volume of approximately 0.6 mL. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Incidence of Treatment Related Major Adverse Cardiac Events | Safety will be reported as the number of incidence of treatment related major adverse cardiac events (MACE). MACE is defined as any of the following: greater than 30 seconds of sustained/symptomatic ventricular tachycardia requiring intervention, cardiogenic shock, unplanned cardiovascular operation due to injection site bleeding, need for new permanent pacemaker, stroke or embolic event to the brain determined by CT scan and death. MACE will be evaluated by the treating physician and assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. | 30 days |
| Number of C-kit+ Products | Feasibility will be reported as the number of c-kit+ products that can be manufactured and delivered to subjects | Day 1 |
| Number of Participants Completing Magnetic Resonance Imaging (MRI) | Feasibility will be reported as the number of participants that complete the baseline, 6-months, and 12-months follow up MRI. | Baseline, 6 Months, 12 months |
| Change in Right Ventricular Function (RVEF) | Efficacy will be reported as the change in right ventricular function assessed as a percentage and will be measuring using serial echocardiograms and MRI scan. | Baseline, 6 Months, 12 months |
| Change in Right Ventricular End-diastolic Volume (RVEDV) | Efficacy will be reported as the change in right ventricular end-diastolic assessed in milliliters per square meter and will be measured using serial echocardiograms and MRI scan. | Baseline, 6 months, 12 months |
| Change in Right Ventricular End-systolic Volume (RVESV) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Incidence of Serious Adverse Events | Incidence of the following after the BDCPA / GLENN Procedure including: All-cause mortality; Cardiovascular mortality; Need for transplantation; Hospitalization for heart failure; Cardiovascular morbidity, including stroke or heart failure or sustained/symptomatic arrhythmias. | Up to 12 months |
Not provided
Inclusion Criteria:
For inclusion in the study, subjects must meet all of the inclusion criteria:
Subjects with hypoplastic left heart syndrome (HLHS) (all types) requiring Stage I Norwood operation.
Exclusion Criteria:
Candidates will be excluded from the study if any of the following conditions are met:
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| Name | Affiliation | Role |
|---|---|---|
| William Mahle, MD | Emory University | Principal Investigator |
| Kristopher Deatrick, MD | University of Maryland | Principal Investigator |
| Richard Ohye, MD | Michigan Medicine Congenital Heart Center/C.S. Mott Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia | 30322 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41258851 | Derived | Kaushal S, Hare JM, Mahle WT, Khan A, Ohye RG, Slesnick TC, Chai PJ, Shashidharan S, Robinson JD, Jone PN, Doman T, Si MS, Lu JC, Bacallao K, Nettina AE, Lamazares R, Saltzman RG, Simpson LM, Li R, Bettencourt JE, Mansoor K, Davis BR, Deatrick KB, Yang J, Mishra R, Everett AD, Lai D, Davis ME. Phase I Randomized Study of Cardiac Stem Cells in Patients With Hypoplastic Left Heart Syndrome: The CHILD Trial. JACC Heart Fail. 2026 Jan;14(1):102723. doi: 10.1016/j.jchf.2025.102723. Epub 2025 Nov 19. | |
| 35394149 |
| Label | URL |
|---|---|
| Interdisciplinary stem cell institute at the University of Miami website | View source |
Not provided
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Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label C-kit+ Cells Group A | Group A is an open-label treatment group determining safety and feasibility. Participants enrolled in this group will be receiving previously harvested c-kit+ cells during their Stage II Bidirectional Cavopulmonary Anastomosis (BDCPA) operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially. c-kit+ cells: The autologous c-kit+ cells will be harvested from participant's right atrial tissue obtained from participant's SOC Norwood Operation. The harvested c-kit+ cells containing up to a total of 12,500 cells/kg will be delivered through 6-10 intramyocardial injections of approximately 100 microliters per injection for a total volume of approximately 0.6 mL. |
| FG001 | C-kit+ Cells Group B | Participants randomized to Group B Treatment Group will receive previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially. c-kit+ cells: The autologous c-kit+ cells will be harvested from participant's right atrial tissue obtained from participant's SOC Norwood Operation. The harvested c-kit+ cells containing up to a total of 12,500 cells/kg will be delivered through 6-10 intramyocardial injections of approximately 100uL per injection for a total volume of approximately 0.6 mL. |
| FG002 | No Intervention Group | Participants randomized to Group B Control Group will receive only their standard of care (SOC) Stage II BDCPA operation without the injection of harvested c-kit+ cells. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Open Label C-kit+ Cells Group A | Group A is an open-label treatment group determining safety and feasibility. Participants enrolled in this group will be receiving previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially. c-kit+ cells: The autologous c-kit+ cells will be harvested from participant's right atrial tissue obtained from participant's SOC Norwood Operation. The harvested c-kit+ cells containing up to a total of 12,500 cells/kg will be delivered through 6-10 intramyocardial injections of approximately 100uL per injection for a total volume of approximately 0.6 mL. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at BDCPA operation |
| 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 Incidence of Treatment Related Major Adverse Cardiac Events | Safety will be reported as the number of incidence of treatment related major adverse cardiac events (MACE). MACE is defined as any of the following: greater than 30 seconds of sustained/symptomatic ventricular tachycardia requiring intervention, cardiogenic shock, unplanned cardiovascular operation due to injection site bleeding, need for new permanent pacemaker, stroke or embolic event to the brain determined by CT scan and death. MACE will be evaluated by the treating physician and assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. | Posted | Number | Events | 30 days |
|
1 year
Not provided
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 | Open Label C-kit+ Cells Group A | Group A is an open-label treatment group determining safety and feasibility. Participants enrolled in this group will be receiving previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially. c-kit+ cells: The autologous c-kit+ cells will be harvested from participant's right atrial tissue obtained from participant's SOC Norwood Operation. The harvested c-kit+ cells containing up to a total of 12,500 cells/kg will be delivered through 6-10 intramyocardial injections of approximately 100uL per injection for a total volume of approximately 0.6 mL. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute right ventricular failure | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua M. Hare, MD | University of Miami | 305-243-5579 | jhare@med.miami.edu |
Not provided
| 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 | Mar 23, 2021 | Dec 29, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D018636 | Hypoplastic Left Heart Syndrome |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
Not provided
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The first 10 participants will be enrolled in Group A to assess safety and feasibility. An additional 22 participants will be enrolled in Group B and will be randomized to either the Treatment or Control Group.
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|
|
Efficacy will be reported as the change in right ventricular end-systolic volume assessed in milliliters per square meter and will be measured using serial echocardiograms and MRI scan. |
| Baseline, 6 months, 12 months |
| Change in Tricuspid Regurgitation | Efficacy will be reported as the change tricuspid regurgitation assessed as a percentage and will be measured using serial echocardiograms and MRI scan. | Baseline, 6 months, 12 months |
| Change in Somatic Growth Velocity - Length (cm) |
Changes in somatic growth velocity will be evaluated by length (cm) over 12 months post study product injection. |
| Baseline, 6 months, 12 months |
| Change in Somatic Growth Velocity - Weight (kg) | Changes in somatic growth velocity will be evaluated by weight (kg) over 12 months post study product injection. | Baseline, 6 months, 12 months |
| Change in Somatic Growth Velocity - Head Circumference (cm) | Changes in somatic growth velocity will be evaluated by head circumference (cm) over 12 months post study product injection. | Baseline, 6 months, 12 months |
| Change in Infant Toddler Quality of Life Survey (ITQOL) - Overall Health | The Infant Toddler Quality of Life Survey (ITQOL) is a validated 47-item parent-reported questionnaire assessing multiple domains of child health, including overall health, physical abilities, growth and development, discomfort/pain, mood, and behavior. Domain scores are transformed to a 0-100 scale, where 0 reflects the poorest health-related quality of life and 100 reflects the best. Higher scores indicate better quality of life. | Baseline, 12 months |
| Incidence of Mortality or Need for Transplantation | Incidence of mortality or need for transplantation after the Stage II BDCPA operation will be reported | Up to 12 months |
| Ann & Robert H. Lurie Children's Hospital of Chicago |
| Chicago |
| Illinois |
| 60611 |
| United States |
| University of Maryland - Division of Cardiac Surgery | Baltimore | Maryland | 21201 | United States |
| Michigan Medicine Congenital Heart Center/C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Derived |
| Kaushal S, Hare JM, Shah AM, Pietris NP, Bettencourt JL, Piller LB, Khan A, Snyder A, Boyd RM, Abdullah M, Mishra R, Sharma S, Slesnick TC, Si MS, Chai PJ, Davis BR, Lai D, Davis ME, Mahle WT. Autologous Cardiac Stem Cell Injection in Patients with Hypoplastic Left Heart Syndrome (CHILD Study). Pediatr Cardiol. 2022 Oct;43(7):1481-1493. doi: 10.1007/s00246-022-02872-6. Epub 2022 Apr 8. |
| 34217109 | Derived | Ali MK, Ichimura K, Spiekerkoetter E. Promising therapeutic approaches in pulmonary arterial hypertension. Curr Opin Pharmacol. 2021 Aug;59:127-139. doi: 10.1016/j.coph.2021.05.003. Epub 2021 Jun 30. |
| BG001 | C-kit+ Cells Group B | Participants randomized to Group B Treatment Group will receive previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially. c-kit+ cells: The autologous c-kit+ cells will be harvested from participant's right atrial tissue obtained from participant's SOC Norwood Operation. The harvested c-kit+ cells containing up to a total of 12,500 cells/kg will be delivered through 6-10 intramyocardial injections of approximately 100uL per injection for a total volume of approximately 0.6 mL. |
| BG002 | No Intervention Group | Participants randomized to Group B Control Group will receive only their standard of care (SOC) Stage II BDCPA operation without the injection of harvested c-kit+ cells. |
| BG003 | Total | Total of all reporting groups |
| Standard Deviation |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | C-kit+ Cells Group B | Participants randomized to Group B Treatment Group will receive previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially. c-kit+ cells: The autologous c-kit+ cells will be harvested from participant's right atrial tissue obtained from participant's SOC Norwood Operation. The harvested c-kit+ cells containing up to a total of 12,500 cells/kg will be delivered through 6-10 intramyocardial injections of approximately 100uL per injection for a total volume of approximately 0.6 mL. |
| OG002 | No Intervention Group | Participants randomized to Group B Control Group will receive only their standard of care (SOC) Stage II BDCPA operation without the injection of harvested c-kit+ cells. |
|
|
| Primary | Number of C-kit+ Products | Feasibility will be reported as the number of c-kit+ products that can be manufactured and delivered to subjects | Posted | Number | Products | Day 1 |
|
|
|
| Primary | Number of Participants Completing Magnetic Resonance Imaging (MRI) | Feasibility will be reported as the number of participants that complete the baseline, 6-months, and 12-months follow up MRI. | Posted | Count of Participants | Participants | Baseline, 6 Months, 12 months |
|
|
|
| Primary | Change in Right Ventricular Function (RVEF) | Efficacy will be reported as the change in right ventricular function assessed as a percentage and will be measuring using serial echocardiograms and MRI scan. | sample size decreases due to attrition | Posted | Mean | Standard Deviation | percentage | Baseline, 6 Months, 12 months |
|
|
|
| Primary | Change in Right Ventricular End-diastolic Volume (RVEDV) | Efficacy will be reported as the change in right ventricular end-diastolic assessed in milliliters per square meter and will be measured using serial echocardiograms and MRI scan. | sample size decreases due to attrition | Posted | Mean | Standard Deviation | milliliters per square meter | Baseline, 6 months, 12 months |
|
|
|
| Primary | Change in Right Ventricular End-systolic Volume (RVESV) | Efficacy will be reported as the change in right ventricular end-systolic volume assessed in milliliters per square meter and will be measured using serial echocardiograms and MRI scan. | sample size decreases due to attrition | Posted | Mean | Standard Deviation | milliliters per square meter | Baseline, 6 months, 12 months |
|
|
|
| Primary | Change in Tricuspid Regurgitation | Efficacy will be reported as the change tricuspid regurgitation assessed as a percentage and will be measured using serial echocardiograms and MRI scan. | sample size decreases due to attrition | Posted | Mean | Standard Deviation | percentage | Baseline, 6 months, 12 months |
|
|
|
| Secondary | Number of Incidence of Serious Adverse Events | Incidence of the following after the BDCPA / GLENN Procedure including: All-cause mortality; Cardiovascular mortality; Need for transplantation; Hospitalization for heart failure; Cardiovascular morbidity, including stroke or heart failure or sustained/symptomatic arrhythmias. | Posted | Number | Events | Up to 12 months |
|
|
|
| Secondary | Change in Somatic Growth Velocity - Length (cm) | Changes in somatic growth velocity will be evaluated by length (cm) over 12 months post study product injection. | sample size decreases due to attrition | Posted | Mean | Standard Deviation | centimeters | Baseline, 6 months, 12 months |
|
|
|
| Secondary | Change in Somatic Growth Velocity - Weight (kg) | Changes in somatic growth velocity will be evaluated by weight (kg) over 12 months post study product injection. | sample size decreases due to attrition | Posted | Mean | Standard Deviation | kilograms | Baseline, 6 months, 12 months |
|
|
|
| Secondary | Change in Somatic Growth Velocity - Head Circumference (cm) | Changes in somatic growth velocity will be evaluated by head circumference (cm) over 12 months post study product injection. | sample size decreases due to attrition | Posted | Mean | Standard Deviation | centimeters | Baseline, 6 months, 12 months |
|
|
|
| Secondary | Change in Infant Toddler Quality of Life Survey (ITQOL) - Overall Health | The Infant Toddler Quality of Life Survey (ITQOL) is a validated 47-item parent-reported questionnaire assessing multiple domains of child health, including overall health, physical abilities, growth and development, discomfort/pain, mood, and behavior. Domain scores are transformed to a 0-100 scale, where 0 reflects the poorest health-related quality of life and 100 reflects the best. Higher scores indicate better quality of life. | sample size decreases due to attrition | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 months |
|
|
|
| Secondary | Incidence of Mortality or Need for Transplantation | Incidence of mortality or need for transplantation after the Stage II BDCPA operation will be reported | Posted | Count of Participants | Participants | Up to 12 months |
|
|
|
| 0 |
| 9 |
| 8 |
| 9 |
| 5 |
| 9 |
| EG001 | C-kit+ Cells Group B | Participants randomized to Group B Treatment Group will receive previously harvested c-kit+ cells during their Stage II BDCPA operation. Harvested c-kit+ cells will be injected into the right ventricle directly intramyocardially. c-kit+ cells: The autologous c-kit+ cells will be harvested from participant's right atrial tissue obtained from participant's SOC Norwood Operation. The harvested c-kit+ cells containing up to a total of 12,500 cells/kg will be delivered through 6-10 intramyocardial injections of approximately 100uL per injection for a total volume of approximately 0.6 mL. | 0 | 8 | 4 | 8 | 6 | 8 |
| EG002 | No Intervention Group | Participants randomized to Group B Control Group will receive only their standard of care (SOC) Stage II BDCPA operation without the injection of harvested c-kit+ cells. | 1 | 8 | 4 | 8 | 6 | 8 |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Right ventricular dysfunction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Coarctation of the aorta | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Necrotising colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Crying | General disorders | MedDRA | Systematic Assessment |
|
| Vascular stent thrombosis | General disorders | MedDRA | Systematic Assessment |
|
| Withdrawal syndrome | General disorders | MedDRA | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Mediastinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
|
| Parainfluenzae virus infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral myocarditis | Infections and infestations | MedDRA | Systematic Assessment |
|
| upper respiratory infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Aortic restenosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Cardiac function disturbance postoperative | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Diaphragmatic injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Feeding intolerance | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Infant irritability | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary vein stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Collateral circulation | Vascular disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | MedDRA | Systematic Assessment |
|
| Vena cava stenosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Venous occlusion | Vascular disorders | MedDRA | Systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Necrotising colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Device embolisation | General disorders | MedDRA | Systematic Assessment |
|
| Drug withdrawal syndrome | General disorders | MedDRA | Systematic Assessment |
|
| Granuloma | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA | Systematic Assessment |
|
| Fungaemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Accidental exposure to product by child | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Medication Error | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Bronchomalacia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary artery occlusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Skin Disorder | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Labile blood pressure | Vascular disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Title | Measurements |
|---|---|
|
| Month 12 |
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 6 |
|
|
| Month 12 |
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| Month 12 |
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