Whole body cooling to reduce brain injury following birth asphyxia

Hypothermia for Encephalopathy in Low and Middle Income Countries Trial - HELIX

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/01/006534

Enrollment

408

Registered

2016-01-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Neonatal Encephalopathy

Interventions

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)

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria (ALL THE THREE BELOW) 1. Age 1.8 kg, Gestation >36 weeks 2. Need for continued resuscitation at 5 minutes after birth and/or 5 minute Apgar score 3. Evidence of moderate or severe encephalopathy on clinical examination within 6 hours of age.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Death or moderate or severe neurodisability at 18 to 22 monthsTimepoint: 18 to 22 months	—

Secondary

Measure	Time frame
Mortality Timepoint: 18 to 22 months;Severe Neuro disabilityTimepoint: 18 to 22 months	—

Countries

Bangladesh, India

Contacts

Public ContactSudhin Thayyil

Maulana Azad Medical College

siddarthramji@gmail.com09968604304

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026