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Trial record 1 of 2 for:    cord blood hypoxia duke
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Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Michael Cotten, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00593242
First received: January 2, 2008
Last updated: May 20, 2014
Last verified: May 2014

January 2, 2008
May 20, 2014
January 2008
June 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls from the Network Hypothermia study. [ Time Frame: during infusions: first 4 postnatal days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00593242 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy
Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy Study 1. Phase I Study of Feasibility and Safety.

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neonatal Hypoxic Ischemic Encephalopathy
  • 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
  • Other: Neurodevelopmental outcomes
    historical controls, no experimental intervention, standard therapies of hypoxic ischemic encephalopathy in the newborn period with autologous cord blood
  • 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
    Intervention: Biological: infusion of autologous cord blood
  • historical control
    Infants who had moderate to severe hypoxic ischemic encephalopathy in the neonatal period but did not receive autologous cord blood cells.
    Intervention: Other: Neurodevelopmental outcomes

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
June 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
up to 14 Days
No
Contact: Kimberley A Fisher, PhD 919-681-4913 kimberley.fisher@duke.edu
Contact: Charles M Cotten, MD MHS 919-681-4844 cotte010@mc.duke.edu
United States
 
NCT00593242
Pro00000412, Duke NPRI01
No
Michael Cotten, Duke University Medical Center
Michael Cotten
Not Provided
Principal Investigator: Charles M Cotten, MD MHS Duke University
Duke University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP