Neonatal Hypoxic Ischemic Encephalopathy | Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy
Neonatal Hypoxic Ischemic Encephalopathy research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Neonatal Hypoxic Ischemic Encephalopathy
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Biological:infusion of autologous cord bloodinfants 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 outcomeshistorical controls, no experimental intervention, standard therapies of hypoxic ischemic encephalopathy in the newborn period with autologous cord blood
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
infusionsinfants 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
historical controlInfants who had moderate to severe hypoxic ischemic encephalopathy in the neonatal period but did not receive autologous cord blood cells.
Start Date: January 2008
Completed Date: January 2017
Phase: Phase 1
Primary Outcome: Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls.
Secondary Outcome: 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
Study sponsors, principal investigator, and references
Principal Investigator: Charles M Cotten, MD MHS
Lead Sponsor: Michael Cotten
Martin PL, Carter SL, Kernan NA, Sahdev I, Wall D, Pietryga D, Wagner JE, Kurtzberg J. Results of the cord blood transplantation study (COBLT): outcomes of unrelated donor umbilical cord blood transplantation in pediatric patients with lysosomal and peroxisomal storage diseases. Biol Blood Marrow Transplant. 2006 Feb;12(2):184-94.
Cotten CM, Murtha AP, Goldberg RN, Grotegut CA, Smith PB, Goldstein RF, Fisher KA, Gustafson KE, Waters-Pick B, Swamy GK, Rattray B, Tan S, Kurtzberg J. Feasibility of autologous cord blood cells for infants with hypoxic-ischemic encephalopathy. J Pediatr. 2014 May;164(5):973-979.e1. doi: 10.1016/j.jpeds.2013.11.036. Epub 2013 Dec 31.