Hypoxic Ischemic EncephalopathyPhase 1NCT00620711
Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
A Phase 1 study testing Olympic Cool Cap in people with Hypoxic Ischemic Encephalopathy, run by Vanderbilt University at 1 site in United States.
Trial summary
The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body. Read more about this study
- Who is it for?
- Ages 30 minutes to 6 hours
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy
- What is being tested?
- Olympic Cool Cap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jul 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 minutes to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Babies < 36 weeks gestation but > 32 0/7 weeks. These babies should be small enough to allow brain cooling with water circulating in a cooling cap applied to the surface of their head
- At least one of the following four criteria which are standard definitions for HIE:
- Apgar 0-3 at 1,5,10 minutes due to hypoxia
- pH less than 7.0
- Base deficit greater than 15
- Need for continued resuscitation due to hypoxia at 10 minutes
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- AND a physical exam with evidence of hypotonia or lethargy or seizures indicative of evolving HIE.
- Intubated
- Age less than 6 hours
- Signed informed consent by parent / legal guardian
- Previous participant has been followed through 7 day head ultrasound.
Who cannot join
- Mild HIE will not be cooled, therefore babies without hypotonia or lethargy and babies who are not intubated will be excluded.
- Gestational age ≥ 36 weeks or < 32 weeks or less than 1200 grams.
- Older than 6 hours of age
- Infant deemed in extremis on clinical exam.
- Survival not expected, i.e. received 3 intravenous doses of epinephrine or more during resuscitation; on infusion of dopamine, dobutamine and/or epinephrine at time of evaluation; and/or has fixed/dilated pupils.
- Evidence of head trauma or skull fracture causing major intracranial hemorrhage
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- Intraventricular hemorrhage
- Weight less than the 5th percentile for gestational age
- Refusal of consent
- Imperforate anus
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe Carell Jr Children's Hospital
Nashville, Tennessee, 37232
About this study
Official title: IRB# 070984 "Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy"
The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.
Read the detailed description
Hypoxic ischemic encephalopathy (HIE) is a potentially devastating disease of the newborn central nervous system (CNS) . Portions of the CNS are deprived of oxygen and blood flow for a period of time which may lead to permanent brain injury manifested as cerebral palsy as well as cognitive defects. Until recently no treatment has been shown to be effective for preventing brain damage, even though it has been demonstrated that the damage is progressive and that there is a window of opportunity to arrest some of the evolving brain injury. However, in May of 2007 the FDA approved the first device specifically designed to ameliorate brain damage in term babies with HIE. This head cooling device which was studied here at Vanderbilt under IRB protocol 990129 Brain Cooling for the treatment of perinatal hypoxic ischemic encephalopathy. We thus have eight years of experience of using this device in term infants. The results of the initial trial demonstrated a successful reduction of HIE induced brain injury from 66% in control infants to 55% in treated babies. There were no significant risks to the application of this device in term babies who are kept cool for 72 hours after experiencing an acute HIE event. The initial trials were limited to term babies because of concern that premature infants would be more at risk for hypothermia induced problems such as hypoglycemia,and coagulopathy. The concern about hypothermia in preterm infants remains a limiting consideration for doing whole body cooling in this population. We propose to apply the cooling cap to the heads of preterm infants who have experienced a significant HIE injury but maintain their body temperature in the normal range (36.1-37° C rectally). Infants will be cooled for up to 72 hours and will be tracked till discharge. Although this is a feasibility study, the participants will also be followed-up at 6, 12 and 24 months of age.
- Conditions
- Hypoxic Ischemic Encephalopathy
- Being tested
- Olympic Cool Cap
- Keywords
- Hypoxic ischemic encephalopathy, HIE, Neonatal encephalopathy, Cooling, hypothermia
- Medical subject headings
- Hypoxia-Ischemia, Brain, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olympic Cool CapDevice
Also called Selective Head Cooling
Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Babies that meet criteria will be offered participation in feasibility trial, there are no other arms. Receives: Device: Olympic Cool Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature.
Measurement of number of participants able to obtain 12 degree cap temperature
Measured: 60 minutes intervals up to 72 hours
Cap Cooled to 12 Degrees Without Reducing Rectal Temperature
Yes/no
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Walsh, Vanderbilt University
- Investigators
- Willaim F Walsh, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620711
- Sponsor's protocol ID
- 070984
- Status last verified
- Jan 2019
- First submitted
- 7 Feb 2008
- Last updated
- 29 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Shankaran 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 24524452
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRB# 070984 "Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy"
- ClinicalTrials.gov ID
- NCT00620711
- Acronym / sponsor ID
- 070984
- Conditions
- Hypoxic Ischemic Encephalopathy
- Keywords
- Hypoxic ischemic encephalopathy, HIE, Neonatal encephalopathy, Cooling, hypothermia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Posted 31 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.
Detailed description
Hypoxic ischemic encephalopathy (HIE) is a potentially devastating disease of the newborn central nervous system (CNS) . Portions of the CNS are deprived of oxygen and blood flow for a period of time which may lead to permanent brain injury manifested as cerebral palsy as well as cognitive defects. Until recently no treatment has been shown to be effective for preventing brain damage, even though it has been demonstrated that the damage is progressive and that there is a window of opportunity to arrest some of the evolving brain injury. However, in May of 2007 the FDA approved the first device specifically designed to ameliorate brain damage in term babies with HIE. This head cooling device which was studied here at Vanderbilt under IRB protocol 990129 Brain Cooling for the treatment of perinatal hypoxic ischemic encephalopathy. We thus have eight years of experience of using this device in term infants. The results of the initial trial demonstrated a successful reduction of HIE induced brain injury from 66% in control infants to 55% in treated babies. There were no significant risks to the application of this device in term babies who are kept cool for 72 hours after experiencing an acute HIE event. The initial trials were limited to term babies because of concern that premature infants would be more at risk for hypothermia induced problems such as hypoglycemia,and coagulopathy. The concern about hypothermia in preterm infants remains a limiting consideration for doing whole body cooling in this population. We propose to apply the cooling cap to the heads of preterm infants who have experienced a significant HIE injury but maintain their body temperature in the normal range (36.1-37° C rectally). Infants will be cooled for up to 72 hours and will be tracked till discharge. Although this is a feasibility study, the participants will also be followed-up at 6, 12 and 24 months of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Olympic Cool CapBabies that meet criteria will be offered participation in feasibility trial, there are no other arms. |
Who may qualify
- Ages
- 30 minutes to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Babies < 36 weeks gestation but > 32 0/7 weeks. These babies should be small enough to allow brain cooling with water circulating in a cooling cap applied to the surface of their head
- At least one of the following four criteria which are standard definitions for HIE:
- AND a physical exam with evidence of hypotonia or lethargy or seizures indicative of evolving HIE.
- Intubated
- Age less than 6 hours
Key exclusion criteria (10 listed)
- Mild HIE will not be cooled, therefore babies without hypotonia or lethargy and babies who are not intubated will be excluded.
- Gestational age ≥ 36 weeks or < 32 weeks or less than 1200 grams.
- Older than 6 hours of age
- Infant deemed in extremis on clinical exam.
- Survival not expected, i.e. received 3 intravenous doses of epinephrine or more during resuscitation; on infusion of dopamine, dobutamine and/or epinephrine at time of evaluation; and/or has fixed/dilated pupils.
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 |
|---|---|---|
| Olympic Cool CapAlso: Selective Head CoolingOlympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE. | Device | 1 |
Primary outcome
Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature.
Time frame: 60 minutes intervals up to 72 hours
Measurement of number of participants able to obtain 12 degree cap temperature
Cap Cooled to 12 Degrees Without Reducing Rectal Temperature
Time frame: 6 hours
Yes/no
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Related trials for Hypoxic Ischemic Encephalopathy
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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
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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.
Willaim F Walsh, MD principal investigator
Vanderbilt University
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 Olympic Cool Cap in people with Hypoxic Ischemic Encephalopathy, run by Vanderbilt University 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 11 inclusion and 10 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 29 Jan 2019. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature. (time frame: 60 minutes intervals up to 72 hours). The study lists 2 primary outcomes in all. 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 NCT00620711, which also lists 1 linked publication.
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 29 Jan 2019.