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CompletedNCT01760629HELIX-IUpdated Feb 24, 2015

Hypothermia for Encephalopathy in Low Income Countries-Feasibilty

An interventional study of Tecotherm-HELIX in Neonatal Encephalopathy, sponsored by Thayyil, Sudhin. Completed at 3 sites in India. Open to participants aged 1 Hour to 1 Month. Per ClinicalTrials.gov, last updated 2015-02-24.

Sponsored by Thayyil, Sudhin · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
1 Hour to 1 Month
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Neonatal Encephalopathy

Keywords

  • Encephalopathy, Newborn, Low and Middle-income countries, Hypothermia
03

In context

Brain Diseases

502 studies on the registry are indexed under Brain Diseases; 141 are open to participants now.

This study's enrollment of 62 is close to the median of 66 across 339 interventional studies indexed under Brain Diseases.

Browse Brain Diseases studies →

Lead sponsor

Thayyil, Sudhin is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 1 Month
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age \< 6 hours, Birth-weight >1.8, Gestation >36 weeks
  2. 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)
  3. Evidence of encephalopathy on clinical examination

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Cooling arm

    Whole body cooling to 33 to 34 C rectal temperature

    Device: Tecotherm-HELIX

Interventions

  • DeviceTecotherm-HELIX

    Whole body cooling using Tecotherm-HELIX

    Also known as: Therapeutic hypothermia, Whole body cooling

06

What researchers measure

Primary outcomes

  1. Feasibility of cooling

    To examine feasibility of whole body cooling within six hours of birth in infants with neonatal encephalopathy

    Time frame: 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.

    Time frame: 2 weeks

07

Study locations

3 sites
  • Manipal Hospital
    Bangalore, India
  • Calicut Medical College
    Calicut, India
  • Institute of Child Health, Madras Medical College
    Chennai, India
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2013, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2013
First posted
Jan 4, 2013
Start
Apr 2013
Primary completionActual
Dec 2014
CompletionActual
Dec 2014
Last update
Feb 24, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01760629
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
First posted
Jan 4, 2013
Start date
Apr 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Feb 24, 2015

Study contacts

Sudhin Thayyil, PhD
principal investigator · Imperial College London
Seetha Shankaran, MD
principal investigator · Wayne State University, Michigan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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