Hypoxic-ischemic EncephalopathyPhase 1NEATNCT00719407
Neonatal Erythropoietin in Asphyxiated Term Newborns
A Phase 1 study testing erythropoietin in people with Hypoxic-ischemic Encephalopathy, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Hypoxic-ischemic Encephalopathy
- What is being tested?
- erythropoietin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Nov 2012
- 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 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≥ 36 weeks gestational age
- Perinatal depression (low Apgar score, need for resuscitation)
- Moderate to severe encephalopathy
Who cannot join
- Specific aEEG findings
- Intrauterine growth restriction
- Severe congenital anomaly, genetic syndrome, metabolic disorder, arthrogryposis, TORCH infection
- Microcephaly
- Infant older than 23.5 hours of age at the time of consent
- Infant judged by an attending physician to be likely to die due to the severity of illness
Show all 9Show fewer
- Polycythemia
- Hypertension
- No in-dwelling line
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial
The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.
Read the detailed description
Newborn infants with birth asphyxia are at high risk of death or long-term neurologic disability; yet therapies for birth asphyxia are currently limited. Erythropoietin (Epo) is a FDA-approved drug that is an effective neuroprotective agent in animal models of birth asphyxia. This is a phase I dose finding multi-center trial that will test the safety and pharmacokinetics of Epo in human infants with birth asphyxia. The long-term objectives of the proposed research are to reduce mortality and to decrease the risk of long-term disabilities in infants who survive beyond the newborn period.
- Conditions
- Hypoxic-ischemic Encephalopathy
- Being tested
- erythropoietin
- Keywords
- birth asphyxia, neonatal encephalopathy, hypoxic-ischemic encephalopathy, neuroprotection, neonate
- Medical subject headings
- Hypoxia-Ischemia, Brain, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythropoietinDrug
Also called Procrit
250 U/kg/dose x 6 doses (n=3); 500 U/kg/dose x 6 doses (n=6); 1,000 U/kg/dose x 6 doses (n=7) 2,500 U/kg/dose x 6 doses (n=8)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | All enrolled patients will be in this single arm, who will receive experimental drug treatment. Receives: Drug: erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse event
Measured: 14 days of life
Secondary outcomes (1)
Pharmacokinetic parameters
Measured: 1 to 11 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund, UCSF Benioff Children's Hospital Oakland, University of Washington, Santa Clara Valley Health & Hospital System
- Responsible party
- Principal investigator, Yvonne Wu, University of California, San Francisco
- Investigators
- Yvonne W Wu, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719407
- Sponsor's protocol ID
- H9299-32566-01
- Other IDs
- Thrasher 02827-0
- Acronym
- NEAT
- Status last verified
- Nov 2012
- First submitted
- 17 Jul 2008
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rogers EE, Bonifacio SL, Glass HC, Juul SE, Chang T, Mayock DE, Durand DJ, Song D, Barkovich AJ, Ballard RA, Wu YW. Erythropoietin and hypothermia for hypoxic-ischemic encephalopathy. Pediatr Neurol. 2014 Nov;51(5):657-62. doi: 10.1016/j.pediatrneurol.2014.08.010. Epub 2014 Aug 27.
PubMed 25439577Shankaran S. Outcomes of hypoxic-ischemic encephalopathy in neonates treated with hypothermia. Clin Perinatol. 2014 Mar;41(1):149-59. doi: 10.1016/j.clp.2013.10.008.
PubMed 24524452Wu 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.
PubMed 23008465
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial
- ClinicalTrials.gov ID
- NCT00719407
- Acronym / sponsor ID
- NEAT / H9299-32566-01
- Conditions
- Hypoxic-ischemic Encephalopathy
- Keywords
- birth asphyxia, neonatal encephalopathy, hypoxic-ischemic encephalopathy, neuroprotection, neonate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Thrasher Research Fund, UCSF Benioff Children's Hospital Oakland, University of Washington, Santa Clara Valley Health & Hospital System
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 21 Jul 2008 (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.
The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.
Detailed description
Newborn infants with birth asphyxia are at high risk of death or long-term neurologic disability; yet therapies for birth asphyxia are currently limited. Erythropoietin (Epo) is a FDA-approved drug that is an effective neuroprotective agent in animal models of birth asphyxia. This is a phase I dose finding multi-center trial that will test the safety and pharmacokinetics of Epo in human infants with birth asphyxia. The long-term objectives of the proposed research are to reduce mortality and to decrease the risk of long-term disabilities in infants who survive beyond the newborn period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: erythropoietinAll enrolled patients will be in this single arm, who will receive experimental drug treatment. |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ≥ 36 weeks gestational age
- Perinatal depression (low Apgar score, need for resuscitation)
- Moderate to severe encephalopathy
Key exclusion criteria (9 listed)
- Specific aEEG findings
- Intrauterine growth restriction
- Severe congenital anomaly, genetic syndrome, metabolic disorder, arthrogryposis, TORCH infection
- Microcephaly
- Infant older than 23.5 hours of age at the time of consent
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 |
|---|---|---|
| erythropoietinAlso: Procrit250 U/kg/dose x 6 doses (n=3); 500 U/kg/dose x 6 doses (n=6); 1,000 U/kg/dose x 6 doses (n=7) 2,500 U/kg/dose x 6 doses (n=8) | Drug | A |
Primary outcome
Serious adverse event
Time frame: 14 days of life
1 secondary outcome
Pharmacokinetic parameters
Time frame: 1 to 11 days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
- Derived from this study: PubMed 25439577Rogers EE, Bonifacio SL, Glass HC, Juul SE, Chang T, Mayock DE, Durand DJ, Song D, Barkovich AJ, Ballard RA, Wu YW. Erythropoietin and hypothermia for hypoxic-ischemic encephalopathy. Pediatr Neurol. 2014 Nov;51(5):657-62. doi: 10.1016/j.pediatrneurol.2014.08.010. Epub 2014 Aug 27.
- Derived from this study: PubMed 24524452Shankaran S. Outcomes of hypoxic-ischemic encephalopathy in neonates treated with hypothermia. Clin Perinatol. 2014 Mar;41(1):149-59. doi: 10.1016/j.clp.2013.10.008.
- Derived from this study: PubMed 23008465Wu 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.
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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.
Yvonne W Wu, MD, MPH principal investigator
University of California, San Francisco
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 erythropoietin in people with Hypoxic-ischemic Encephalopathy, run by University of California, San Francisco 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 9 Nov 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse event (time frame: 14 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00719407, which also lists 3 linked publications.
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 9 Nov 2012.