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

June 26, 2020 updated by: University of California, San Francisco

Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital Research Institute
    • California
      • Palo Alto, California, United States
        • Stanford University
      • San Francisco, California, United States, 94143
        • UCSF
      • Santa Clara, California, United States
        • Kaiser Permanente, Santa Clara
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 minutes to 1 day (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Erythropoietin
1000 U/kg/dose x 5 doses
Drug: Erythropoietin
1000 U/kg/dose IV x 5 doses
Other Names:
  • Procrit
PLACEBO_COMPARATOR: Normal saline
Drug: Normal saline
placebo: NS IV x 5 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Washington University School of Medicine
Seattle Children's Hospital
Stanford University
Kaiser Permanente
Children's National Research Institute
Thrasher Research Fund
Arkansas Children's Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (ESTIMATE)

August 1, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2020

Last Update Submitted That Met QC Criteria

June 26, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0055603-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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