Hypoxic Ischemic EncephalopathyPhase 1/2NCT01138176
Whole Body Cooling Using Phase Changing Material
A Phase 1/2 study testing Cooling in people with Hypoxic Ischemic Encephalopathy, run by Robertson, Nicola, M.D. at 1 site in India.
Trial summary
A prospective randomized control trial to examine safety and effectiveness of whole body cooling to a rectal temperature of 33.5 C using phase changing material in neonatal encephalopathy. Effectiveness will be defined by examining the stability of rectal temperature during cooling. 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?
- Cooling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2009to Aug 2011
- Phase
- Phase 1/2
- 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 Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Apgar score of <5 at 5 minutes or continued resuscitation at 5 minutes
- Neonatal encephalopathy
Who cannot join
- Imminent death
- Major congenital malformations
- Gestation <36 weeks
- Birthweight less than 1.8 kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Randomized Control Trial of Whole Body Cooling in Neonatal Encephalopathy Using Phase Changing Material
A prospective randomized control trial to examine safety and effectiveness of whole body cooling to a rectal temperature of 33.5 C using phase changing material in neonatal encephalopathy. Effectiveness will be defined by examining the stability of rectal temperature during cooling. Monitoring of vital signs, infection screen, blood counts, coagulation screen, liver and renal function tests, cranial US and MR imaging will be performed on recruited infants to evaluate safety of cooling. EEG will be performed on day 4 and hearing evaluation at discharge. Neurodevelopmental evaluation will be performed at 1 year of age.
Read the detailed description
Meta-analyses of these trials show that therapeutic hypothermia increases survival with normal neurological function (pooled risk ratio of 1.53) with a number needed to treat of 8 (95% confidence interval (CI) 5 - 17) and in survivors reduces the rates of severe disability and cerebral palsy. Therapeutic hypothermia is now widely offered to moderately or severely asphyxiated infants in high-income countries.
The global burden of disease estimates indicate that perinatal asphyxia is a very significant problem in low and mid resourced settings. There are, however, several compelling reasons why the efficacy and safety data on therapeutic hypothermia from high-income countries cannot be extrapolated to neonatal units in transitional countries, such as India; in particular there is a lack of effective low tech servo controlled cooling equipments that can be used in these settings. This pilot phase II randomized control trial will examine the efficacy of phase changing material in providing satisfactory therapeutic hypothermia in neonatal encephalopathy, in a mid resource setting.
- Conditions
- Hypoxic Ischemic Encephalopathy
- Being tested
- Cooling
- Keywords
- Neonatal encephalopathy, Therapeutic hypothermia, Phase changing material, MR imaging
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolingProcedure or surgery
Also called Therapeutic hypothermia, Whole body cooling
Reduction of rectal temperature to 33.5 C
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Not described Receives: Procedure: Cooling |
| Cooling | Experimental | Reduction of rectal temperature to 33.5 C for 72 hours Receives: Procedure: Cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of cooling
Percentage of time for which rectal temperature is maintained between 33 to 34 C during the 72 hours of therapeutic hypothermia
Measured: 72 hours
Secondary outcomes (5)
Brain tissue injury on MR imaging
Basal ganglia, white matter and cortical lesions scored from 0 to 3
Measured: 7 to 10 days
Adverse neurodevelopment
severe neurodevelopmental impairment (defined as scores of <60 on neurological examination30 and/or a developmental score < 2SD (DASII) below the mean and/or GMFCS>II), microcephaly (head circumference <2 SD below mean), severe visual or hearing impairment
Measured: 12 months
Mortality
Death until hospital discharge
Measured: 4 weeks
EEG abnormality
Abnormal background activity
Measured: 4 days
Sepsis
Blood or CSF culture positive sepsis
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startJul 2009
- Primary completionJan 2011 (estimated)
- Study completionAug 2011 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robertson, Nicola, M.D.
- Collaborators
- Thayyil, Sudhin
- Investigators
- Balraj Guhan, MD, Principal investigator, Calicut Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138176
- Sponsor's protocol ID
- PCM09
- Status last verified
- Jun 2010
- First submitted
- 2 Jun 2010
- Last updated
- 7 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Control Trial of Whole Body Cooling in Neonatal Encephalopathy Using Phase Changing Material
- ClinicalTrials.gov ID
- NCT01138176
- Acronym / sponsor ID
- PCM09
- Conditions
- Hypoxic Ischemic Encephalopathy
- Keywords
- Neonatal encephalopathy, Therapeutic hypothermia, Phase changing material, MR imaging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Robertson, Nicola, M.D.
- Collaborators
- Thayyil, Sudhin
- Study start
- Jul 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 7 Jun 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.
A prospective randomized control trial to examine safety and effectiveness of whole body cooling to a rectal temperature of 33.5 C using phase changing material in neonatal encephalopathy. Effectiveness will be defined by examining the stability of rectal temperature during cooling. Monitoring of vital signs, infection screen, blood counts, coagulation screen, liver and renal function tests, cranial US and MR imaging will be performed on recruited infants to evaluate safety of cooling. EEG will be performed on day 4 and hearing evaluation at discharge. Neurodevelopmental evaluation will be performed at 1 year of age.
Detailed description
Meta-analyses of these trials show that therapeutic hypothermia increases survival with normal neurological function (pooled risk ratio of 1.53) with a number needed to treat of 8 (95% confidence interval (CI) 5 - 17) and in survivors reduces the rates of severe disability and cerebral palsy. Therapeutic hypothermia is now widely offered to moderately or severely asphyxiated infants in high-income countries.
The global burden of disease estimates indicate that perinatal asphyxia is a very significant problem in low and mid resourced settings. There are, however, several compelling reasons why the efficacy and safety data on therapeutic hypothermia from high-income countries cannot be extrapolated to neonatal units in transitional countries, such as India; in particular there is a lack of effective low tech servo controlled cooling equipments that can be used in these settings. This pilot phase II randomized control trial will examine the efficacy of phase changing material in providing satisfactory therapeutic hypothermia in neonatal encephalopathy, in a mid resource setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | Procedure: Cooling |
| Cooling | Experimental | Procedure: CoolingReduction of rectal temperature to 33.5 C for 72 hours |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Apgar score of <5 at 5 minutes or continued resuscitation at 5 minutes
- Neonatal encephalopathy
Key exclusion criteria (4 listed)
- Imminent death
- Major congenital malformations
- Gestation <36 weeks
- Birthweight less than 1.8 kg
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 |
|---|---|---|
| CoolingAlso: Therapeutic hypothermia, Whole body coolingReduction of rectal temperature to 33.5 C | Procedure or surgery | Cooling, Standard care |
Primary outcome
Stability of cooling
Time frame: 72 hours
Percentage of time for which rectal temperature is maintained between 33 to 34 C during the 72 hours of therapeutic hypothermia
5 secondary outcomes
Brain tissue injury on MR imaging
Time frame: 7 to 10 days
Adverse neurodevelopment
Time frame: 12 months
Mortality
Time frame: 4 weeks
EEG abnormality
Time frame: 4 days
Sepsis
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2010.
- UCL Institute for Women's HealthLink provided by the sponsor.
Related trials for Hypoxic Ischemic Encephalopathy
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
RecruitingPhase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Neonatal Seizure, Neonatal Encephalopathy
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.
Balraj Guhan, MD principal investigator
Calicut Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cooling in people with Hypoxic Ischemic Encephalopathy, run by Robertson, Nicola, M.D. 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 2 inclusion and 4 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 7 Jun 2010. 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. 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 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.
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?
Results are not available in the source record.
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?
Stability of cooling (time frame: 72 hours). 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 7 Jun 2010.