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Hormone Therapy
Erythropoietin for Asphyxia
Phase 1
Waitlist Available
Led By Robert D. Christensen, MD
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Infant 6 hours of age or less
Weight greater than 2500 grams (5.5 lbs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test whether a hormone called erythropoietin can help reduce brain damage in newborns who didn't get enough oxygen at birth.
Who is the study for?
This trial is for newborns who experienced oxygen deprivation at birth, reflected by very low Apgar scores within the first 5 minutes of life. They should be no older than 6 hours, weigh more than 5.5 lbs, and have a central venous line already in place.Check my eligibility
What is being tested?
The study is testing high doses of Erythropoietin (Epo), a hormone that might protect brain cells from damage caused by lack of oxygen during birth.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions typical to hormone treatments such as irritation at injection site or mild changes in blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby is 6 hours old or younger.
Select...
I weigh more than 5.5 pounds.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,953 Previous Clinical Trials
2,670,465 Total Patients Enrolled
3 Trials studying Asphyxia
8,614 Patients Enrolled for Asphyxia
Robert D. Christensen, MDPrincipal InvestigatorUniversity of South Florida
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant does not meet the required health criteria.My baby is 6 hours old or younger.I weigh more than 5.5 pounds.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this prophylactic been officially sanctioned by the US Food and Drug Administration?
"As it is still in its initial testing stage, the safety rating of this treatment was assessed as a 1 due to lack of evidence for both efficacy and security."
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