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Trial record 1 of 1 for:    A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy
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A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy ((HIE))

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ClinicalTrials.gov Identifier: NCT02612155
Recruitment Status : Completed
First Posted : November 23, 2015
Results First Posted : August 25, 2020
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
The Robertson Foundation
Information provided by (Responsible Party):
Michael Cotten, Duke University

Tracking Information
First Submitted Date  ICMJE November 19, 2015
First Posted Date  ICMJE November 23, 2015
Results First Submitted Date  ICMJE August 5, 2020
Results First Posted Date  ICMJE August 25, 2020
Last Update Posted Date August 25, 2020
Actual Study Start Date  ICMJE March 30, 2017
Actual Primary Completion Date August 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2020)
  • Survival at One Year [ Time Frame: 1 year ]
    Number of participants alive at one year.
  • Number of Participants With Bayley III Scores in All Three Domains > or Equal to 85 [ Time Frame: 1 year ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2015)
  • Survival at One Year [ Time Frame: One year ]
  • Percentage of subjects with Bayley III scores in all three domains > or equal to 85 [ Time Frame: One year ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2020)
  • Mortality Rate [ Time Frame: 1 year ]
    (Number of participants who died/total number of participants) x 100
  • Number of Subjects Who Experience Seizures [ Time Frame: During hospitalization, approximately 4-92 days ]
  • Number of Subjects Who Require iNO (Inhaled Nitric Oxide) Use [ Time Frame: During hospitalization, approximately 4-92 days ]
  • Number of Subjects Who Require ECMO [ Time Frame: During hospitalization, approximately 4-92 days ]
    ECMO (extracorporeal membrane oxygenation) is a technique of providing prolonged cardiac and respiratory support to persons whose heart and lungs are unable to provide an adequate amount of gas exchange or perfusion to sustain life.
  • Number of Subjects Who Require Gastrostomy Tube (G-tube) Feeding [ Time Frame: During hospitalization, approximately 4-92 days ]
  • Number of Subjects Who Are Discharged on Anti-epileptic Medication [ Time Frame: At hospital discharge, approximately 4-92 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2015)
  • Mortality Rate [ Time Frame: One year ]
  • Percentage of subjects who experience seizures [ Time Frame: One year ]
  • Percentage of subjects who require iNO use [ Time Frame: One year ]
  • Percentage of subjects who require ECMO [ Time Frame: One year ]
  • Percentage of subjects who require G-tube feeding [ Time Frame: One year ]
  • Percentage of subjects who are discharged on anti-epileptic meds [ Time Frame: One year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy
Official Title  ICMJE A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic (HIE)
Brief Summary This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.
Detailed Description The purpose of this phase II study is to assess the safety and efficacy of up to two intravenous infusions of autologous volume and red blood cell reduced nucleated umbilical cord blood cells as compared with placebo in neonates with neonatal encephalopathy undergoing hypothermia treatment. Efficacy will be estimated by one year survival and score on Bayley III scores in all three domains equal to or greater than 85. This will be a randomized, double-blind, placebo controlled multi-site trial of up to 160 infants who qualify for cooling.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
Intervention  ICMJE
  • Biological: Infusion of autologous cord blood
    Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells.
  • Biological: Placebo
    Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit.
Study Arms  ICMJE
  • Experimental: Intervention cell recipients
    Experimental: infusions: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have autologous nucleated cord blood cells available for infusion will receive up to two infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment
    Intervention: Biological: Infusion of autologous cord blood
  • Placebo Comparator: Placebo recipients
    Control: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have cord blood available for infusion will receive placebo (a mix of autologous cord blood red blood cells and plasma) infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment
    Intervention: Biological: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2020)
35
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2015)
160
Actual Study Completion Date  ICMJE August 5, 2019
Actual Primary Completion Date August 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. NICHD Neonatal Research Network Hypothermia Trial inclusion criteria
  2. Mothers must have consented or given verbal assent for cord blood collection at delivery, and cord blood must be available for volume and red blood cell reduction before 45 hours of age
  3. The infant must be able to receive at least one dose of autologous cord blood before 48 hours of age
  4. All infants must have signs of encephalopathy within 6 hours of age

Exclusion Criteria:

  1. Major congenital or chromosomal abnormalities
  2. Severe growth restriction (birth weight <1800 g)
  3. Opinion by attending neonatologist that the study may interfere with treatment or safety of subject
  4. Moribund neonates for whom no further treatment is planned
  5. Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have active syphilis or CMV infection in pregnancy
  6. Infants suspected of overwhelming sepsis
  7. ECMO initiated or likely in the first 48 hours of life
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02612155
Other Study ID Numbers  ICMJE Pro00066647
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Cotten, Duke University
Study Sponsor  ICMJE Michael Cotten
Collaborators  ICMJE The Robertson Foundation
Investigators  ICMJE
Principal Investigator: Michael Cotten, MD Duke University
PRS Account Duke University
Verification Date August 2020

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