Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00593242 |
|
Recruitment Status :
Completed
First Posted : January 14, 2008
Last Update Posted : March 21, 2017
|
Sponsor:
Michael Cotten
Information provided by (Responsible Party):
Michael Cotten, Duke University
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neonatal Hypoxic Ischemic Encephalopathy | Biological: infusion of autologous cord blood Other: Neurodevelopmental outcomes | Phase 1 |
The purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own)umbilical cord blood cells in term gestation newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth whose mothers have previously consented to providing cord blood cells for the Carolinas Cord Blood Bank or other public or private bank that uses accepted standards for collection and handling of cells, or provided verbal consent for cord blood collection for the possibility of their baby's participation in this trial, can receive their own cord blood cells if an adequate number of cells that meet Carolinas Cord Blood Bank Quality standards are available in the first 14 postnatal days. Study activities also include serial blood draws concurrent with clinically indicated blood draws with a total volume of no more than 5 milliliters (1 teaspoon) from all study related tests. Babies will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months at Duke's Special Infant Care Clinic. MRI's will be obtained per clinical routine and results will be analyzed and described in study reports.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 52 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy Study 1. Phase I Study of Feasibility and Safety. |
| Study Start Date : | January 2008 |
| Actual Primary Completion Date : | January 2017 |
| Actual Study Completion Date : | January 2017 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: infusions
infants who arrive at the study site within the first 14 postnatal days and had a history of moderate to severe hypoxic ischemic encephalopathy, and have cells available for infusion that pass Carolinas Cord Blood Bank Quality checks Outcomes will be measured at 22-26 months fby neurodevelopment assessment
|
Biological: infusion of autologous cord blood
infants who meet study enrollment criteria for history of moderate to severe hypoxic ischemic encephalopathy in the neonatal period will receive up to 4 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells. The dose for each infusion is 5x10e7 cells/kg |
|
historical control
Infants who had moderate to severe hypoxic ischemic encephalopathy in the neonatal period but did not receive autologous cord blood cells.
|
Other: Neurodevelopmental outcomes
historical controls, no experimental intervention, standard therapies of hypoxic ischemic encephalopathy in the newborn period with autologous cord blood |
Primary Outcome Measures :
- Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls. [ Time Frame: during infusions: first 18 postnatal days ]
Secondary Outcome Measures :
- Secondary endpoints of this pilot study will include preliminary efficacy as measured by neurodevelopmental function at 4 - 6 months and 9 - 12 months of age [ Time Frame: 1 year ]
- neuroimaging results will be collected and compared with available results from prior trials of therapies in this population, and from a previously collected set of images from normal term newborns through the first year of life. [ Time Frame: 6 months ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 14 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Mothers must have consented for cord blood collection at delivery
- cord blood must be available for extraction of stem cells.
- >34 weeks gestation
- cord or neonatal pH<7.0 or base deficit>16 milliequivalents per liter (mEq/L) or history of acute perinatal event
- either a 10 minute Apgar < 5 or continued need for ventilation.
- All infants must have signs of encephalopathy within 6 hours of age.
Exclusion Criteria:
- Inability to enroll by 14 days of age.
- Presence of known chromosomal anomaly.
- Presence of major congenital anomalies.
- Severe intrauterine growth restriction (weight <1800g)
- Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
- Parents refuse consent.
- Attending neonatologist refuses consent.
- Failure to collect the infant's cord blood and/or laboratory unable to process cord blood.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593242
Locations
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
Sponsors and Collaborators
Michael Cotten
Investigators
| Principal Investigator: | Charles M Cotten, MD MHS | Duke University |
Additional Information:
Publications of Results:
Other Publications:
Publications of Results:
Other Publications:
| Responsible Party: | Michael Cotten, Associate Professor of Pediatrics, Duke University |
| ClinicalTrials.gov Identifier: | NCT00593242 |
| Other Study ID Numbers: |
Pro00000412 Duke NPRI01 |
| First Posted: | January 14, 2008 Key Record Dates |
| Last Update Posted: | March 21, 2017 |
| Last Verified: | March 2017 |
Keywords provided by Michael Cotten, Duke University:
|
hypoxic-ischemic encephalopathy autologous cord blood cells newborn infants |
Additional relevant MeSH terms:
|
Brain Diseases Brain Ischemia Hypoxia-Ischemia, Brain Ischemia Hypoxia Pathologic Processes Central Nervous System Diseases |
Nervous System Diseases Signs and Symptoms, Respiratory Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Hypoxia, Brain |