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A study to see if cooling babies with birth asphyxia is beneficial

A randomized controlled trial of therapeutic hypothermia for neonatal hypoxic-ischemic encephalopathy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/05/003693
Enrollment
50
Registered
2013-05-29
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- Neonates with hypoxic ischemic encephalopathy

Interventions

Intervention1: Therapeutic hypothermia: Babies who fulfill the inclusion criteria will be cooled using phase changing mattress to a target temperature of 33.5 C (33 to 34 C). This will be maintained

Sponsors

Christian Medical College Vellore
Lead Sponsor
St Olavs University hospital Trondheim Norway
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age of newborn : 2. GA >35 wks and Birth weight > 1800 g 3. PHYSIOLOGICAL CRITERIA- Any 1 of the following ï?® ABG (Umbilical cord / 1st postnatal hr) pH - 12 ï?® Apgar score ï?® Ventilation required for at least 10 minutes as part of resuscitation at birth 4. NEUROLOGICAL CRITERIA- Seizures (OR) Evidence of moderate or severe encephalopathy (3 of 6 criteria in modified Sarnat)

Exclusion criteria

Exclusion criteria: 1. Lack of consent 2. Major congenital malformations 3. Imminent death anticipated at the time of assessment for eligibility

Design outcomes

Primary

MeasureTime frame
MRI abnormalities at 5 ±1 days of lifeTimepoint: MRI abnormalities at 5 ±1 days of life

Secondary

MeasureTime frame
Chorioamnionitis-placental histology & IL6 levels Amiel-Tison General movement assessment Death or neurodevelopmental impairment at 18 monthsTimepoint: Short term (before discharge from hospital)&/or at 7 days Intermediate term (10-15 weeks) Long term: 18 months

Countries

India

Contacts

Public ContactDr Niranjan Thomas

Christian Medical College, Vellore

niranjan@cmcvellore.ac.in04162283311

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 20, 2026