AsphyxiaPhase 1NCT00491413
Erythropoietin for Infants With Brain Injuries Due to Oxygen Deprivation at Birth
A Phase 1 study testing epoetin in people with Asphyxia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Erythropoietin (Epo) is a hormone normally found in the body that may protect brain cells from damage due to lack of oxygen. This study will evaluate the safety of high-dose Epo in infants who did not get enough oxygen during birth. Read more about this study
- Who is it for?
- Ages Up to 6 hours
- Conditions the study is for
- Asphyxia
- What is being tested?
- epoetin
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant 6 hours of age or less
- Apgar scores less than or equal to 3 at 1 and 5 minutes
- Weight greater than 2500 grams (5.5 lbs)
- Central venous line in place
Who cannot join
- infants are ineligible if they do not meet the inclusion criteria above
Trial locations and contacts
1 site in 1 country.
United States1 site
All Children's Hospital
St. Petersburg, Florida, 33701
Robert D. Christensen, MD, 727-502-8168, rchriste@hsc.usf.edu
Stacey M. Levitt, MD, 727-553-1570, slevitt@hsc.usf.edu
About this study
Official title: High Dose Erythropoietin for Neonates With Asphyxia
Erythropoietin (Epo) is a hormone normally found in the body that may protect brain cells from damage due to lack of oxygen. This study will evaluate the safety of high-dose Epo in infants who did not get enough oxygen during birth.
Read the detailed description
Damage to the central nervous system as a result of oxygen deprivation at birth is a major cause of life-long mental and developmental handicaps. When there is not enough oxygen in the blood (hypoxemia) the brain is deprived of oxygen. Some brain cells respond by producing Epo. Epo then binds to oxygen-deprived brain cells. This binding triggers chemical reactions within the brain cell that prevent cell death. Epo also reduces inflammation around the brain cells and acts as an antioxidant. In animal studies, recombinant Epo (rEpo) administration, even up to six hours after oxygen deprivation, reduced subsequent brain injury by 50% to 70%.
Epo has been used by neonatologists to stimulate erythropoiesis (red blood cell production) and reduce the incidence of blood transfusions. Doses of rEpo required for protection of brain cells are considerably higher than those traditionally used by neonatologists.
This study will evaluate the pharmacokinetics, biologic effect, and safety of high dose Epo in neonates with brain injury due to hypoxemia.
Within six hours of birth, each eligible infant will receive one dose of rEpo intravenously. Any infants who require a lumbar puncture during the first week of life will have levels of natural Epo and rEpo in their spinal fluid measured. Blood tests will be used to measure the antioxidant effect of Epo and the impact on red blood cell production. Neurodevelopmental outcome will be measured at 6 and 12 months of age.
- Conditions
- Asphyxia
- Being tested
- epoetin
- Keywords
- neurodevelopmental outcomes
- Medical subject headings
- Asphyxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsphyxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Robert D. Christensen, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491413
- Sponsor's protocol ID
- R21HD042308
- Status last verified
- Aug 2003
- First submitted
- 22 Jun 2007
- Last updated
- 26 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Erythropoietin for Neonates With Asphyxia
- ClinicalTrials.gov ID
- NCT00491413
- Acronym / sponsor ID
- R21HD042308
- Conditions
- Asphyxia
- Keywords
- neurodevelopmental outcomes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- First posted
- 26 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Erythropoietin (Epo) is a hormone normally found in the body that may protect brain cells from damage due to lack of oxygen. This study will evaluate the safety of high-dose Epo in infants who did not get enough oxygen during birth.
Detailed description
Damage to the central nervous system as a result of oxygen deprivation at birth is a major cause of life-long mental and developmental handicaps. When there is not enough oxygen in the blood (hypoxemia) the brain is deprived of oxygen. Some brain cells respond by producing Epo. Epo then binds to oxygen-deprived brain cells. This binding triggers chemical reactions within the brain cell that prevent cell death. Epo also reduces inflammation around the brain cells and acts as an antioxidant. In animal studies, recombinant Epo (rEpo) administration, even up to six hours after oxygen deprivation, reduced subsequent brain injury by 50% to 70%.
Epo has been used by neonatologists to stimulate erythropoiesis (red blood cell production) and reduce the incidence of blood transfusions. Doses of rEpo required for protection of brain cells are considerably higher than those traditionally used by neonatologists.
This study will evaluate the pharmacokinetics, biologic effect, and safety of high dose Epo in neonates with brain injury due to hypoxemia.
Within six hours of birth, each eligible infant will receive one dose of rEpo intravenously. Any infants who require a lumbar puncture during the first week of life will have levels of natural Epo and rEpo in their spinal fluid measured. Blood tests will be used to measure the antioxidant effect of Epo and the impact on red blood cell production. Neurodevelopmental outcome will be measured at 6 and 12 months of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infant 6 hours of age or less
- Apgar scores less than or equal to 3 at 1 and 5 minutes
- Weight greater than 2500 grams (5.5 lbs)
- Central venous line in place
Key exclusion criteria (1 listed)
- infants are ineligible if they do not meet the inclusion criteria above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epoetin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D. Christensen, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing epoetin in people with Asphyxia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2007.