NCT01760629

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 24, 2015

Status Verified

February 1, 2015

Enrollment Period

1.7 years

First QC Date

January 2, 2013

Last Update Submit

February 20, 2015

Conditions

Neonatal Encephalopathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Feasibility of cooling

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

    72 hours

Secondary Outcomes (1)

  • Short term morbidity

    2 weeks

Study Arms (1)

Cooling arm

EXPERIMENTAL

Whole body cooling to 33 to 34 C rectal temperature

Device: Tecotherm-HELIX

Interventions

Tecotherm-HELIXDEVICE

Whole body cooling using Tecotherm-HELIX

Also known as: Therapeutic hypothermia, Whole body cooling
Cooling arm

Eligibility Criteria

Age1 Hour - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Manipal Hospital

Bangalore, India

Location

Calicut Medical College

Calicut, India

Location

Institute of Child Health, Madras Medical College

Chennai, India

Location

Related Publications (1)

  • 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.

    PMID: 29637198DERIVED

MeSH Terms

Conditions

Brain DiseasesHypothermia

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Officials

  • Sudhin Thayyil, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

  • Seetha Shankaran, MD

    Wayne State University, Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 4, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 24, 2015

Record last verified: 2015-02

Locations

IN(3)