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Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO) (NEATO)

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: NCT01913340
Recruitment Status : Completed
First Posted : August 1, 2013
Results First Posted : July 13, 2020
Last Update Posted : July 13, 2020
Sponsor:
Collaborators:
Thrasher Research Fund
Seattle Children's Hospital
Arkansas Children's Hospital Research Institute
Washington University School of Medicine
Children's National Research Institute
Stanford University
Kaiser Permanente
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability. Cooling therapy (hypothermia) provides some protection, but about half of affected infants still have a poor outcome. This clinical trial will determine if the drug erythropoietin, given with hypothermia, is safe to use as a treatment that may further reduce the risk of neurologic deficits after HIE.

Condition or disease Intervention/treatment Phase
Hypoxic-ischemic Encephalopathy Neonatal Encephalopathy Birth Asphyxia Drug: Erythropoietin Drug: Normal saline Phase 1 Phase 2

Detailed Description:

This phase I/II clinical trial is designed to demonstrate:

  1. The feasibility of recruiting, enrolling and following 50 patients with moderate to severe HIE at 5 sites, while meeting specified recruitment and follow-up target goals.
  2. The safety of high-dose Epo therapy in neonates with HIE with respect to systemic organ function and general growth parameters.
  3. The value of brain MRI/MRS performed at 4-7 days of age as a biomarker of motor function at 12 months of age.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study
Study Start Date : September 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Active Comparator: Erythropoietin
1000 U/kg/dose x 5 doses
Drug: Erythropoietin
1000 U/kg/dose IV x 5 doses
Other Name: Procrit

Placebo Comparator: Normal saline Drug: Normal saline
placebo: NS IV x 5 doses




Primary Outcome Measures :
  1. Markers of Organ Function [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    The investigators will monitor organ function and adverse events until hospital discharge from the neonatal intensive care unit


Secondary Outcome Measures :
  1. Alberta Infant Motor Scale (AIMS) [ Time Frame: 12 months ]
    The AIMS consists of 58 items, including 4 positions: prone (21 items), supine (9 items), sitting (12 items), & standing (16 items). Each item is scored as 'observed' or 'not observed'. Total score range is 0-58, scored as percentile ranks after a raw score is obtained and plotted against age at testing, based on validated norms.


Other Outcome Measures:
  1. Warner Initial Developmental Evaluation (WIDEA) [ Time Frame: 12 months ]
    A 43-item questionnaire developed and standardized to assess the functional domains of self-care, motor function, communication and social cognition in young children. Self care sub-scale score range 17-68. Mobility score range is 9-36. Communication score range is 13-52. Social Cognition score range is 11-44. Total scale range is 50-200. Higher scores mean higher functioning. Lower scores mean lower functioning.



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.


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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newborns ≥ 36 weeks gestation, < 23 hours of age at time of consent, must meet all 3 Inclusion Criteria to be eligible for the study:

    1. Perinatal depression = at least one of the following: a) Apgar ≤5 at 10 min or b) required resuscitation (endotracheal or mask ventilation, or chest compressions) at 10 min or c) pH < 7.0 or base deficit ≥15 in cord, arterial, or venous blood obtained at <60 min of age;
    2. Moderate to severe encephalopathy = at least 3 of 6 modified Sarnat criteria present between 1-6 h of birth: a) reduced level of consciousness; b) decreased spontaneous activity; c) hypotonia; d) decreased suck; e) decreased Moro reflex; or f) respiratory distress including periodic breathing or apnea; and
    3. Hypothermia = passive or active cooling begun by 6 hours of age.

Exclusion Criteria:

  • Intrauterine growth restriction (BW <1800 g);
  • Major congenital malformation; suspected genetic syndrome, metabolic disorder or TORCH infection;
  • Head circumference < 2 SD for gestation;
  • Infant for whom withdrawal of supportive care is being considered; or
  • Anticipated inability to collect primary endpoint at 12 months of age.

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): NCT01913340


Locations
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United States, Arkansas
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
United States, California
Stanford University
Palo Alto, California, United States
UCSF
San Francisco, California, United States, 94143
Kaiser Permanente, Santa Clara
Santa Clara, California, United States
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of California, San Francisco
Thrasher Research Fund
Seattle Children's Hospital
Arkansas Children's Hospital Research Institute
Washington University School of Medicine
Children's National Research Institute
Stanford University
Kaiser Permanente
Investigators
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Principal Investigator: Yvonne W Wu, MD, MPH University of California, San Francisco
Publications of Results:
Other Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01913340    
Other Study ID Numbers: P0055603-01
First Posted: August 1, 2013    Key Record Dates
Results First Posted: July 13, 2020
Last Update Posted: July 13, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
erythropoietin
therapeutic hypothermia
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Asphyxia Neonatorum
Hypothermia
Asphyxia
Central Nervous System Diseases
Nervous System Diseases
Body Temperature Changes
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Epoetin Alfa
Hematinics