Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 50
- Locations
- 7
- Primary Endpoint
- Markers of Organ Function
Study Overview
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.
Detailed Description
This phase I/II clinical trial is designed to demonstrate:
- 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.
- The safety of high-dose Epo therapy in neonates with HIE with respect to systemic organ function and general growth parameters.
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Minutes to 24 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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;
- •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
- •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.
Arms & Interventions
Erythropoietin
1000 U/kg/dose x 5 doses
Intervention: Erythropoietin (Drug)
Normal saline
Intervention: Normal saline (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Alberta Infant Motor Scale (AIMS)(12 months)