High-dose Erythropoietin or placebo for birth asphyxia and neonatal encephalopathy

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"Study looking at High-dose Erythropoietin with standard care or placebo with standard of care has better outcomes for infants with HIE"
Age:
newborn
Gender:
Any
Healthy Volunteers:
No
Keywords:
birth asphyxia, neonatal encephalopathy
Type:
Drug study, Phase 3
Investigator:
Description
Hypoxic-ischemic encephalopathy (HIE) occurs when a baby gets reduced blood flow and oxygen to the brain near the time of birth. This results in death or neurologic disabilities including cerebral palsy and cognitive impairment in up to half of affected infants. This study will determine if the drug erythropoietin (Epo) added to hypothermia (usual therapy) will improve outcomes for infants suffering from HIE.
This study requires
Medical record review
Placenta pathology
Blood and urine tests as part of standard care
MRI/EEG as part of standard care
Your infant will be given 5 doses of the study drug (Epo or placebo) through an IV line, at the following times: 1, 2, 3, 4 and 7 days of age. The first dose will be given as soon as possible within 24 hours of birth. The final study drug dose will be given at 7 days of age, or on the last day of hospitalization, whichever comes first
Who can participate?
Inclusion Criteria:

- ≥ 36 weeks of gestational age

- Receiving active or passive whole body cooling/hypothermia since < 6 hours of age

- Perinatal depression based on at least one of the following:

1. Apgar score < 5 at 10 minutes, or

2. Need for resuscitation at 10 minutes (i.e., endotracheal or mask ventilation, or chest compressions), or

3. pH < 7.00 in cord, arterial, or venous blood < 60 minutes of age

4. Base deficit ≥ 15 mmol/L in cord, arterial, or venous blood < 60 minutes of age

- Moderate to severe encephalopathy (based on modified Sarnat exam) present between 1-6 hours after birth


Exclusion Criteria:

- Study drug unlikely to be administered within 26 hours of birth

- Infant has living twin (or higher order multiple) who is also being cooled

- Birth weight < 1800 g (e.g., intrauterine growth restriction)

- Genetic or congenital condition that affects neurodevelopment or requires multiple surgeries (e.g., congenital viral infection, hydrops, complex congenital heart disease, severe dysmorphic features, etc.)

- Head circumference < 30 cm

- Redirection of care is being considered due to moribund condition

- Patient anticipated to be unavailable for evaluation at age 2

- Polycythemia (hematocrit > 65%)

- Parents with diminished capacity and autonomy

- Infant is participating in another interventional study (note: does not include observational studies)
Resources
Schedule
Study duration and period
Your infant will be in this study until the final follow-up visit at 2 years of age. Participation in this study will require less than 1 hour during the nursery hospitalization, four 15-30 minute phone calls, and a 3-hour follow-up visit at age 2. Thus, the total time required for the study is 6 hours at most, spread out over 2 year’s time.
Recruitment period
From Oct. 21, 2016
Location
UC Davis Department of Pediatrics
2516 Stockton Boulevard
Sacramento, CA 95817
Contact
Rosa Regina Pesavento
Research Topic
Conditions:
  • Neonatal Encephalopathy
  • Birth Asphyxia

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