Perinatal AsphyxiaPhase 2/3NCT02002039
Neuroprotective Role of Erythropoietin in Perinatal Asphyxia
A Phase 2/3 study testing Erythropoietin in people with Perinatal Asphyxia, run by Sheri Kashmir Institute of Medical Sciences at 1 site in India.
Trial summary
Whether Erythropoietin improves the neurological outcomes of neonates with perinatal asphyxia. Read more about this study
- Who is it for?
- Ages Up to 6 hours
- Conditions the study is for
- Perinatal Asphyxia
- What is being tested?
- Erythropoietin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2012to Jun 2016
- Phase
- Phase 2/3
- 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
- Babies with severe perinatal asphyxia with moderate to severe HIE in the immediate neonatal period
Who cannot join
- Babies with congenital malformations
- Small for gestational age babies
- Babies with chromosomal anomalies
Trial locations and contacts
1 site in 1 country.
India1 site
Sheri-Kashmir Institute of Medical Sciences
Srinagar, Jammu and Kashmir
About this study
Official title: Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial
Whether Erythropoietin improves the neurological outcomes of neonates with perinatal asphyxia.
Read the detailed description
will be a randomized trial
- Conditions
- Perinatal Asphyxia
- Being tested
- Erythropoietin
- Keywords
- Perinatal asphyxia, erythropoietin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
Also called erhthropoietin beta
500 units /kg /day every other day for 5 doses
| Study group | Role | What they receive |
|---|---|---|
| erythropoietin, perinatal asphyxia, | Active comparator | Treatment group Receives: Drug: Erythropoietin |
| Normal saline, perinatal asphyxia | Placebo comparator | Normal saline on alternate days for 5 doses starting from first 6 hours of life Receives: Drug: Erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or moderate or severe disability at 18-22 months of age
Measured: 18-22 months
Secondary outcomes (3)
Disability
Severe disability was defined as GMFCS grade of level 3-5, hearing impairment requiring hearing aids, bilateral cortical visual impairment with no useful vision or Bayley Mental Development Index Score less than 70. Moderate disability was defined as Bayley Mental Developmental Index Score between 70-84 and any one of the following criteria: GMFCS grade of level 2, hearing impairment with no amplification or persistent seizure disorder.
Measured: 18-22 months
Bayley psychomotor development index
Measured: 18-22 months months
Hearing loss at 18-22 months
Measured: 18-22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheri Kashmir Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Mushtaq, Sheri Kashmir Institute of Medical Sciences
- Investigators
- Feroz Shaheen, MD, Study chair, SKIMSProf. WAjid Ali, Study director, SKIMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002039
- Sponsor's protocol ID
- Erythropoietin 01
- Status last verified
- Oct 2016
- First submitted
- 27 Nov 2013
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02002039
- Acronym / sponsor ID
- Erythropoietin 01
- Conditions
- Perinatal Asphyxia
- Keywords
- Perinatal asphyxia, erythropoietin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sheri Kashmir Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Dec 2013 (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.
Whether Erythropoietin improves the neurological outcomes of neonates with perinatal asphyxia.
Detailed description
will be a randomized trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erythropoietin, perinatal asphyxia, | Active comparator | Drug: ErythropoietinTreatment group |
| Normal saline, perinatal asphyxia | Placebo comparator | Drug: ErythropoietinNormal saline on alternate days for 5 doses starting from first 6 hours of life |
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Babies with severe perinatal asphyxia with moderate to severe HIE in the immediate neonatal period
Key exclusion criteria (3 listed)
- Babies with congenital malformations
- Small for gestational age babies
- Babies with chromosomal anomalies
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: erhthropoietin beta500 units /kg /day every other day for 5 doses | Drug | Normal saline, perinatal asphyxia, erythropoietin, perinatal asphyxia, |
Primary outcome
Death or moderate or severe disability at 18-22 months of age
Time frame: 18-22 months
3 secondary outcomes
Disability
Time frame: 18-22 months
Bayley psychomotor development index
Time frame: 18-22 months months
Hearing loss at 18-22 months
Time frame: 18-22 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 14 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Feroz Shaheen, MD study chair
SKIMS
Prof. WAjid Ali study director
SKIMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Erythropoietin in people with Perinatal Asphyxia, run by Sheri Kashmir Institute of Medical Sciences at 1 site in India.
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 1 inclusion and 3 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 14 Oct 2016. 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 India. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Death or moderate or severe disability at 18-22 months of age (time frame: 18-22 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 14 Oct 2016.