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TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia

NCT00147030 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2016-05-11

Study results available
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Summary

Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability.

This study aims to determine whether whole body cooling to 33-34°C is a safe treatment that improves survival, without severe neurological or neurodevelopmental impairments at 18 months, of term infants suffering perinatal asphyxial encephalopathy.

Conditions

Interventions

PROCEDURE

Whole body mild induced hypothermia

Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia

Sponsors & Collaborators

Principal Investigators

  • Denis Azzopardi, MD; FRCPCH · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2006-11-30
Completion
2008-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00147030 on ClinicalTrials.gov