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

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypoxic-ischemic Encephalopathy; Neonatal Encephalopathy; Birth Asphyxia

Intervention: Erythropoietin (Drug); Normal saline (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Yvonne W Wu, MD, MPH, Principal Investigator, Affiliation: University of California, San Francisco

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.

Clinical Details

Official title: Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Markers of organ function

Secondary outcome: Alberta Infant Motor Score (AIMS)

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

Minimum age: N/A. Maximum age: 24 Hours. Gender(s): Both.

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.

Locations and Contacts

Arkansas Children's Hospital Research Institute, Little Rock, Arkansas 72202, United States

Stanford University, Palo Alto, California, United States

UCSF, San Francisco, California 94143, United States

Kaiser Permanente, Santa Clara, Santa Clara, California, United States

Children's National Medical Center, Washington DC, District of Columbia 20010, United States

Washington University, St. Louis, Missouri 63110, United States

Seattle Children's Hospital, Seattle, Washington 98105, United States

Additional Information

Related publications:

Wu YW, Bauer LA, Ballard RA, Ferriero DM, Glidden DV, Mayock DE, Chang T, Durand DJ, Song D, Bonifacio SL, Gonzalez FF, Glass HC, Juul SE. Erythropoietin for neuroprotection in neonatal encephalopathy: safety and pharmacokinetics. Pediatrics. 2012 Oct;130(4):683-91. doi: 10.1542/peds.2012-0498. Epub 2012 Sep 24.

Starting date: September 2013
Last updated: May 26, 2015

Page last updated: August 23, 2015

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