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Competing randomized trial of an experimental therapy limited initial enrollment. The trial was completed, published, and the experimental therapy became broadly desired. Given this, the investigators felt it best to terminate this competing study.
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| Name | Class |
|---|---|
| Texas Medical Center Regenerative Medicine Consortium | UNKNOWN |
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The purpose of this study is to investigate the use of autologous umbilical cord blood (UCB) mononuclear cells to mitigate hypoxic neurologic injury among infants with high-risk congenital diaphragmatic hernia (CDH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous umbilical cord blood | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous umbilical cord blood | Biological | 6×10^6 mononuclear cells isolated from the patient's own umbilical cord blood per dose. 4 total doses administered intravenously over 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by vital sign monitoring (heart rate) | daily for 7 days following the initial infusion | |
| Safety as assessed by vital sign monitoring (systolic blood pressure) | daily for 7 days following the initial infusion | |
| Safety as assessed by vital sign monitoring (diastolic blood pressure) | daily for 7 days following the initial infusion | |
| Safety as assessed by vital sign monitoring (temperature) | daily for 7 days following the initial infusion | |
| Safety as assessed by pulmonary status (indicated by peak inspiratory pressure (PIP)) | daily for 7 days following the initial infusion | |
| Safety as assessed by pulmonary status (indicated by positive end expiratory pressure (PEEP)) | daily for 7 days following the initial infusion | |
| Safety as assessed by pulmonary status (indicated by respiratory rate (RR)) | daily for 7 days following the initial infusion | |
| Safety as assessed by pulmonary status (indicated by Fraction of inspired oxygen (FiO2)) | daily for 7 days following the initial infusion | |
| Safety as assessed by presence of new infiltrates or altered aeration upon chest radiography | daily for 7 days following the initial infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 2 years after birth | |
| Length of stay in hospital | from birth to discharge or death, whichever occurs first (discharge occurs at about 2-4 months after birth) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew T. Harting, MD, MS | 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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| Label | URL |
|---|---|
| The Comprehensive Center for CDH Care at Children's Memorial Hermann Hospital and The University of Texas Health Science Center in Houston (Texas Medical Center) | View source |
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| Safety as assessed by cardiovascular status (indicated by heart rate) | daily for 7 days following the initial infusion |
| Safety as assessed by cardiovascular status (indicated by systolic blood pressure) | daily for 7 days following the initial infusion |
| Safety as assessed by cardiovascular status (indicated by diastolic blood pressure) | daily for 7 days following the initial infusion |
| Safety as assessed by cardiovascular status (indicated by changes in cardiovascular pharmacologic support) | daily for 7 days following the initial infusion |
| Safety as assessed by infection status (indicated by body temperature) | daily for 7 days following the initial infusion |
| Safety as assessed by infection status (indicated by white blood cell count) | 7 days following the initial infusion |
| Safety as assessed by infection status (indicated by physical signs of infection) | daily for 7 days following the initial infusion |
| Safety as assessed by liver function (indicated by Alanine aminotransferase (ALT) levels) | 7 days following the initial infusion |
| Safety as assessed by liver function (indicated by aspartate aminotransferase (AST) levels | 7 days following the initial infusion |
| Safety as assessed by liver function (indicated by bilirubin levels) | 7 days following the initial infusion |
| Safety as assessed by liver function (indicated by albumin levels) | 7 days following the initial infusion |
| Safety as assessed by blood urea nitrogen (BUN) levels | 7 days following the initial infusion |
| Safety as assessed by creatinine levels | 7 days following the initial infusion |
| Safety as assessed by carbon dioxide (CO2) levels | 7 days following the initial infusion |
| Safety as assessed by glucose levels | 7 days following the initial infusion |
| Safety as assessed by serum chloride levels | 7 days following the initial infusion |
| Safety as assessed by serum potassium levels | 7 days following the initial infusion |
| Safety as assessed by serum sodium levels | 7 days following the initial infusion |
| Neurologic/neurodevelopmental status as assessed by intracranial abnormalities upon magnetic resonance imaging (MRI) | within 14 days of discharge (discharge occurs at about 2-4 months after birth) |
| Neurologic/neurodevelopmental status as assessed by receipt of neurologic pharmacologic medications | at the time of discharge (which is about 2-4 months after birth) |
| Neurologic/neurodevelopmental status as assessed by Bayley Scales of Infant and Toddler Development-III (BSID-III) | The Bayley-III is an individually-administered examination that assesses the current developmental functioning of infants and young children from birth to 42 months of age. The Bayley is a standardized, norm-referenced measure that assesses development in Cognitive, Language and Motor domains. Composite standard scores can be derived that have a mean of 100 and a standard deviation of 15. | 2 years after birth |
| Progression of pulmonary hypertension as assessed by echocardiography |
| within 24 hours of birth, prior to operative repair (occurs between day 2 & 14 of life), prior to discharge (usually 2-6 months), and after discharge (2wks-6 months following discharge) |
| Duration of extracorporeal membrane oxygenation (ECMO) support | days from ECMO initiation until decannulation (an average of 3 weeks) |
| Duration of ventilatory support | from initiation of ventilation until extubation (an average of 8 weeks) |
| ID | Term |
|---|---|
| D065630 | Hernias, Diaphragmatic, Congenital |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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