Neonatal EncephalopathyHELIX-INCT01760629
Hypothermia for Encephalopathy in Low Income Countries-Feasibilty
A study testing Tecotherm-HELIX in people with Neonatal Encephalopathy, run by Thayyil, Sudhin at 3 sites in India.
Trial summary
Whole body cooling improves survival with normal neurological outcome after neonatal encephalopathy in high-income countries. However, cooling equipments used in the high-income countries are expensive and unsuitable for wider use in low and middle-income countries (LMIC). Read more about this study
- Who is it for?
- Ages 1 hour to 1 month
- Conditions the study is for
- Neonatal Encephalopathy
- What is being tested?
- Tecotherm-HELIX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesIndia
- Study dates
- Apr 2013to Dec 2014
- Phase
- Interventional
- 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 1 hour to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age < 6 hours, Birth-weight >1.8, Gestation >36 weeks
- Need for resuscitation at birth and 5 minute Apgar score <6 (in born babies) or Lack of cry by 5 minutes of age (for out-born babies)
- Evidence of encephalopathy on clinical examination
Who cannot join
- Infants in moribound condition, where death is imminent
- Absent heart rate at 10 minute of age
- Major life threatening congenital malformation
- Lack of cooling equipment
- Lack of parental or physician consent
Trial locations and contacts
3 sites in 1 country.
India3 sites
Manipal Hospital
Bangalore
Calicut Medical College
Calicut
Institute of Child Health, Madras Medical College
Chennai
About this study
Official title: Hypothermia for Encephalopathy in Low Income Countries-Feasibility
Whole body cooling improves survival with normal neurological outcome after neonatal encephalopathy in high-income countries. However, cooling equipments used in the high-income countries are expensive and unsuitable for wider use in low and middle-income countries (LMIC). We had previously conducted a randomised controlled trial of whole body cooling using phase changing material in south India. Although cooling was provided, there were wide temperature fluctuations.
Aim: To examine efficacy of the low technology cooling equipment (Tecotherm-HELIX) in administering effective and stable whole body cooling in encephalopathic infants.
Read more
Methods: After informed parental consent (and ethical approvals), we will administer 72 hours of whole body cooling (rectal temperature 33 to 34C) to a total 50 encephalopathic infants (aged <6 hours) admitted to the neonatal units at Calicut Medical College and Madras Medical College, over a six month period. To induce cooling, the infants will be kept on the cooling mattress. Temperature will be continuously measured for 80 hours using a rectal probe connected to a digital data logger.
The primary outcome will be the effective cooling time i.e. percentage of time (95% CI) for which the temperature remains between 33 to 340C during the intended cooling period.
- Conditions
- Neonatal Encephalopathy
- Being tested
- Tecotherm-HELIX
- Keywords
- Encephalopathy, Newborn, Low and Middle-income countries, Hypothermia
- Medical subject headings
- Brain Diseases, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecotherm-HELIXDevice
Also called Therapeutic hypothermia, Whole body cooling
Whole body cooling using Tecotherm-HELIX
| Study group | Role | What they receive |
|---|---|---|
| Cooling arm | Experimental | Whole body cooling to 33 to 34 C rectal temperature Receives: Device: Tecotherm-HELIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of cooling
To examine feasibility of whole body cooling within six hours of birth in infants with neonatal encephalopathy
Measured: 72 hours
Secondary outcomes (1)
Short term morbidity
Short-term neonatal morbidity - Hypotension requiring inotropes, cardiac arrhythmias (other than bradycardia), coagulopathy/thrombocytopenia requiring blood products, respiratory failure requiring ventilatory support, seizures, and subcutaneous fat necrosis.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thayyil, Sudhin
- Collaborators
- Government Medical College, Kozhikode, Institute for Child Health, Madras Medical College, Egmore, Chennai, Wayne State University, Manipal Hospital, India
- Responsible party
- Sponsor
- Investigators
- Sudhin Thayyil, PhD, Principal investigator, Imperial College LondonSeetha Shankaran, MD, Principal investigator, Wayne State University, Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760629
- Sponsor's protocol ID
- 3332/002
- Acronym
- HELIX-I
- Status last verified
- Feb 2015
- First submitted
- 2 Jan 2013
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oliveira V, Kumutha JR, E N, Somanna J, Benkappa N, Bandya P, Chandrasekeran M, Swamy R, Mondkar J, Dewang K, Manerkar S, Sundaram M, Chinathambi K, Bharadwaj S, Bhat V, Madhava V, Nair M, Lally PJ, Montaldo P, Atreja G, Mendoza J, Bassett P, Ramji S, Shankaran S, Thayyil S. Hypothermia for encephalopathy in low-income and middle-income countries: feasibility of whole-body cooling using a low-cost servo-controlled device. BMJ Paediatr Open. 2018 Mar 23;2(1):e000245. doi: 10.1136/bmjpo-2017-000245. eCollection 2018.
PubMed 29637198
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothermia for Encephalopathy in Low Income Countries-Feasibility
- ClinicalTrials.gov ID
- NCT01760629
- Acronym / sponsor ID
- HELIX-I / 3332/002
- Conditions
- Neonatal Encephalopathy
- Keywords
- Encephalopathy, Newborn, Low and Middle-income countries, Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Thayyil, Sudhin
- Collaborators
- Government Medical College, Kozhikode, Institute for Child Health, Madras Medical College, Egmore, Chennai, Wayne State University, Manipal Hospital, India
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Jan 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.
Whole body cooling improves survival with normal neurological outcome after neonatal encephalopathy in high-income countries. However, cooling equipments used in the high-income countries are expensive and unsuitable for wider use in low and middle-income countries (LMIC). We had previously conducted a randomised controlled trial of whole body cooling using phase changing material in south India. Although cooling was provided, there were wide temperature fluctuations.
Aim: To examine efficacy of the low technology cooling equipment (Tecotherm-HELIX) in administering effective and stable whole body cooling in encephalopathic infants.
Methods: After informed parental consent (and ethical approvals), we will administer 72 hours of whole body cooling (rectal temperature 33 to 34C) to a total 50 encephalopathic infants (aged <6 hours) admitted to the neonatal units at Calicut Medical College and Madras Medical College, over a six month period. To induce cooling, the infants will be kept on the cooling mattress. Temperature will be continuously measured for 80 hours using a rectal probe connected to a digital data logger.
The primary outcome will be the effective cooling time i.e. percentage of time (95% CI) for which the temperature remains between 33 to 340C during the intended cooling period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cooling arm | Experimental | Device: Tecotherm-HELIXWhole body cooling to 33 to 34 C rectal temperature |
Who may qualify
- Ages
- 1 hour to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age < 6 hours, Birth-weight >1.8, Gestation >36 weeks
- Need for resuscitation at birth and 5 minute Apgar score <6 (in born babies) or Lack of cry by 5 minutes of age (for out-born babies)
- Evidence of encephalopathy on clinical examination
Key exclusion criteria (5 listed)
- Infants in moribound condition, where death is imminent
- Absent heart rate at 10 minute of age
- Major life threatening congenital malformation
- Lack of cooling equipment
- Lack of parental or physician 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 |
|---|---|---|
| Tecotherm-HELIXAlso: Therapeutic hypothermia, Whole body coolingWhole body cooling using Tecotherm-HELIX | Device | Cooling arm |
Primary outcome
Feasibility of cooling
Time frame: 72 hours
To examine feasibility of whole body cooling within six hours of birth in infants with neonatal encephalopathy
1 secondary outcome
Short term morbidity
Time frame: 2 weeks
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 24 Feb 2015.
- Derived from this study: PubMed 29637198Oliveira V, Kumutha JR, E N, Somanna J, Benkappa N, Bandya P, Chandrasekeran M, Swamy R, Mondkar J, Dewang K, Manerkar S, Sundaram M, Chinathambi K, Bharadwaj S, Bhat V, Madhava V, Nair M, Lally PJ, Montaldo P, Atreja G, Mendoza J, Bassett P, Ramji S, Shankaran S, Thayyil S. Hypothermia for encephalopathy in low-income and middle-income countries: feasibility of whole-body cooling using a low-cost servo-controlled device. BMJ Paediatr Open. 2018 Mar 23;2(1):e000245. doi: 10.1136/bmjpo-2017-000245. eCollection 2018.
Related trials for Neonatal Encephalopathy
Not yet recruitingObservational study
This Multicentre Study Compares aCUP-E With Standard Electrodes During aEEG Monitoring in NICU Newborns at Risk of Encephalopathy, Assessing Recording Quality, Reliability, Ease of Use and Safety.
Encephalopathy
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
RecruitingPhase 2/3
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
Hypoxic-Ischemic Encephalopathy
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
RecruitingObservational study
The NIH MINI Study: Metabolism, Infection, and Immunity in Inborn Errors of Metabolism
Oxidative Phosphorylation Deficiencies, Electron Transport Chain Disorders, Mitochondrial
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.
Sudhin Thayyil, PhD principal investigator
Imperial College London
Seetha Shankaran, MD principal investigator
Wayne State University, Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tecotherm-HELIX in people with Neonatal Encephalopathy, run by Thayyil, Sudhin at 3 sites 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 3 inclusion and 5 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 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Feasibility 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?
On the ClinicalTrials.gov record for NCT01760629, 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 24 Feb 2015.