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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of California, San Francisco
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 Santa Clara
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01913340
First received: July 29, 2013
Last updated: April 11, 2014
Last verified: April 2014
  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

  • Gross Motor Function Classification Scale (GMFCS) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    This is a validated and widely used tool for classifying severity of motor impairment.


Estimated Enrollment: 50
Study Start Date: September 2013
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Erythropoietin Drug: Erythropoietin
1000 U/kg/dose IV every 48 hours x 5
Other Name: Procrit
Placebo Comparator: Normal saline Drug: Normal saline
placebo: 1 cc NS IV every 48 hours x 5

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
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

Contacts
Contact: Yvonne W Wu, MD, MPH 415-353-3678 wuy@neuropeds.ucsf.edu
Contact: Karin Knowles 415-514-8139 KnowlesK@peds.ucsf.edu

Locations
United States, Arkansas
Arkansas Children's Hospital Research Institute Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Sarah Mulkey, MD       MulkeySarah@uams.edu   
Principal Investigator: Sarah Mulkey, MD         
Sub-Investigator: Vivian Yap, MD         
United States, California
UCSF Recruiting
San Francisco, California, United States, 94143
Contact: Yvonne W Wu, MD, MPH    415-353-3678    wuy@neuropeds.ucsf.edu   
Contact: Karin Knowles    415-514-8139    KnowlesK@peds.ucsf.edu   
Sub-Investigator: Roberta A Ballard, MD         
Principal Investigator: Yvonne W Wu, MD, MPH         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington DC, District of Columbia, United States, 20010
Contact: Taeun Chang, MD    202-259-0170    tchang@cnmc.org   
Principal Investigator: Taeun Chang, MD         
Sub-Investigator: An Massaro, MD         
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Amit Mathur, MD    314-454-4031    mathur_a@kids.wustl.edu   
Principal Investigator: Amit Mathur, MD         
Sub-Investigator: Robert McKinstry, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Dennis Mayock, MD    206-543-5257    mayock@u.washington.edu   
Principal Investigator: Dennis Mayock, MD         
Sub-Investigator: Sandra Juul, MD         
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 Santa Clara
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: April 11, 2014
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
Hypoxia-Ischemia, Brain
Hypoxia, Brain
Asphyxia
Brain Ischemia
Hypothermia
Brain Damage, Chronic
Delirium
Encephalitis
Hepatic Encephalopathy
Neurotoxicity Syndromes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Body Temperature Changes
Signs and Symptoms
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases

ClinicalTrials.gov processed this record on July 20, 2014