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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Thrasher Research Fund
Seattle Children's Hospital
Arkansas Children's Hospital Research Institute
Washington University School of Medicine
Children's Research Institute
Stanford University
Kaiser Permanente
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01913340
First received: July 29, 2013
Last updated: March 14, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Hypoxic-ischemic Encephalopathy
Neonatal Encephalopathy
Birth Asphyxia
Drug: Erythropoietin
Drug: Normal saline
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Markers of organ function [ Time Frame: Participants will be followed for the duration of hospital stay, an expected averaged of 2 weeks ] [ Designated as safety issue: Yes ]
    The investigators will monitor organ function and adverse events until hospital discharge from the neonatal intensive care unit


Secondary Outcome Measures:
  • Alberta Infant Motor Score (AIMS) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The instrument contains 58 items that are broken down into 4 motor sub-scales: prone, supine, sit and stand. The assessment entails observation only with minimal handling, and is typically completed in 10-20 minutes.


Other Outcome Measures:
  • Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    A 43-item questionnaire developed and standardized to assess the functional domains of self-care, motor function, communication and social cognition in young children


Estimated Enrollment: 50
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   up to 24 Hours   (Child)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913340

Locations
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 DC, District of Columbia, United States, 20010
United States, Missouri
Washington University
St. 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 Research Institute
Stanford University
Kaiser Permanente
Investigators
Principal Investigator: Yvonne W Wu, MD, MPH University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01913340     History of Changes
Other Study ID Numbers: P0055603-01 
Study First Received: July 29, 2013
Last Updated: March 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
erythropoietin
therapeutic hypothermia

Additional relevant MeSH terms:
Asphyxia Neonatorum
Hypothermia
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Asphyxia
Body Temperature Changes
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on July 24, 2016