Hypoxic-Ischemic EncephalopathyPhase 2CerebroHIENCT01059461
Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy
A Phase 2 study testing Cerebrolysin® in people with Hypoxic-Ischemic Encephalopathy, run by Sahar M.A. Hassanein, MD at 2 sites in Egypt.
Trial summary
The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic encephalopathy after hospital discharge. Read more about this study
- Who is it for?
- Ages 3 to 6 months
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy
- What is being tested?
- Cerebrolysin®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- Mar 2011to Sep 2013
- Phase
- Phase 2
- 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 3 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Severe intrauterine growth retardation.
- Congenital malformations.
- Suspected inborn error of metabolism.
- Suspected inherited neurologic disease.
- Intracranial hemorrhage
- Meningitis
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Children's Hospital, Faculty of Medicine, Ain Shams University
Cairo, Cairo Governorate, 11381
Children's Hospital, Faculty of Medicine, Ain Shams University
Cairo, 11381
About this study
Official title: Phase 2 Nerve Growth Factor (Cerebrolysin®) for Treatment of Neonatal Hypoxic Ischemic Encephalopathy
The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic encephalopathy after hospital discharge.
Read the detailed description
Infants with perinatal history of moderate to severe Hypoxic ischemic encephalopathy HIE will receive 10 injections of cerebrolysin IM. Assessment of neurodevelopment will be done before , 3 and 6 months after therapy
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Being tested
- Cerebrolysin®
- Keywords
- Hypoxic Ischemic Encephalopathy (HIE), Perinatal Asphyxia, Nerve growth factor, Cerebrolysin, Cerebral palsy
- Medical subject headings
- Hypoxia-Ischemia, Brain, Hereditary Sensory and Autonomic Neuropathies, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebrolysin®Drug
Also called Nerve Growth Factor
injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
| Study group | Role | What they receive |
|---|---|---|
| Cerebrolysin®, neuroregeneration | Experimental | Injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal) Receives: Drug: Cerebrolysin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects during cerebrolysin therapy (one course).
weekly physical , neurological examination and parents' reported fever or convulsion during cerebrolysin injection course (10 injections).
Measured: 3 months
Secondary outcomes (1)
Neurodevelopmental follow up after 6 and 9 months of cerebrolysin injection.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startMar 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahar M.A. Hassanein, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sahar M.A. Hassanein, MD, Ain Shams University
- Investigators
- Sahar MA Hassanein, MD, Principal investigator, Children's Hospital, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059461
- Sponsor's protocol ID
- IRB 00006379
- Acronym
- CerebroHIE
- Status last verified
- Sep 2013
- First submitted
- 29 Jan 2010
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Nerve Growth Factor (Cerebrolysin®) for Treatment of Neonatal Hypoxic Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT01059461
- Acronym / sponsor ID
- CerebroHIE / IRB 00006379
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Keywords
- Hypoxic Ischemic Encephalopathy (HIE), Perinatal Asphyxia, Nerve growth factor, Cerebrolysin, Cerebral palsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sahar M.A. Hassanein, MDUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 Feb 2010 (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 whether nerve growth factor (cerebrolysin®) therapy will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic encephalopathy after hospital discharge.
Detailed description
Infants with perinatal history of moderate to severe Hypoxic ischemic encephalopathy HIE will receive 10 injections of cerebrolysin IM. Assessment of neurodevelopment will be done before , 3 and 6 months after therapy
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebrolysin®, neuroregeneration | Experimental | Drug: Cerebrolysin®Injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal) |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Severe intrauterine growth retardation.
- Congenital malformations.
- Suspected inborn error of metabolism.
- Suspected inherited neurologic disease.
- Intracranial hemorrhage
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 |
|---|---|---|
| Cerebrolysin®Also: Nerve Growth Factorinjection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal) | Drug | Cerebrolysin®, neuroregeneration |
Primary outcome
Side effects during cerebrolysin therapy (one course).
Time frame: 3 months
weekly physical , neurological examination and parents' reported fever or convulsion during cerebrolysin injection course (10 injections).
1 secondary outcome
Neurodevelopmental follow up after 6 and 9 months of cerebrolysin injection.
Time frame: 9 months
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 13 Sep 2013.
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The PROTECT-HIE Pilot Trial
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
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Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
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Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
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.
Sahar MA Hassanein, MD principal investigator
Children's Hospital, Faculty of Medicine, Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cerebrolysin® in people with Hypoxic-Ischemic Encephalopathy, run by Sahar M.A. Hassanein, MD at 2 sites in Egypt.
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 0 inclusion and 6 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 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Side effects during cerebrolysin therapy (one course). (time frame: 3 months). It is what the study was designed to measure, not a finding.
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 13 Sep 2013.