Whole body cooling to reduce brain injury following birth asphyxia

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/01/006534
• Date of registration: 18-01-2016
• Prospective Registration: No
• Primary sponsor: Imperial college London
• Public title: Whole body cooling to reduce brain injury following birth asphyxia
• Scientific title: Hypothermia for Encephalopathy in Low and Middle Income Countries Trial - HELIX
• Date of first enrolment: 01-08-2015
• Target sample size: 408
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10967
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

Bangladesh, India

Contacts

• Name: Sudhin Thayyil
• Affiliation: Maulana Azad Medical College

• Name: Siddarth Ramji
• Affiliation: Maulana Azad Medical College

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion Criteria (ALL THE THREE BELOW)

1. Age < 6 hours, Birth-weight >1.8 kg, Gestation >36 weeks

2. Need for continued resuscitation at 5 minutes after birth and/or 5 minute Apgar score <6 (in babies born at hospital) or lack of cry by 5 minutes of age (for babies born at home)

3. Evidence of moderate or severe encephalopathy on clinical examination within 6 hours of age.


Exclusion criteria: • Exclusion Criteria

1. Absent heart rate at 10 minute of age despite adequate resuscitation.

2. Major life threatening congenital malformation.

3. Migrant family or parents unable/unlikely to come back for follow up at 18 months.

4. Lack of parental consent.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Neonatal Encephalopathy

Intervention(s)

Intervention1: Whole body cooling: Reduction of core body temperature to 33.5 C for 72 hours
Control Intervention1: Usual care: Normothermia (36.5 to 37.5 C)

Primary Outcome(s)

Death or moderate or severe neurodisability at 18 to 22 monthsTimepoint: 18 to 22 months

Secondary Outcome(s)

Mortality

Timepoint: 18 to 22 months

Severe Neuro disabilityTimepoint: 18 to 22 months

Secondary ID(s)

NIL

Source(s) of Monetary Support

Bill and Miranda Gates Foundation and Imperial College London BRC

Ethics review

Status: Approved
Approval date: 20/04/2015
Contact:

Imperial College London Research Ethics Committee

Status: Approved
Approval date: 07/07/2015
Contact:

IEC MMC

Status: Approved
Approval date: 17/07/2015
Contact:

LTM Ethics

Status: Not Approved
Approval date:
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IGH EC

Status: Not Approved
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KEM Mumbai

Status: Not Approved
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MAMC EC

Status: Not Approved
Approval date:
Contact:

Ratna Hospital Pune