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Whole Body Cooling Using Phase Changing Material

NCT01138176 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2010-06-07

No results posted yet for this study

Summary

A prospective randomized control trial to examine safety and effectiveness of whole body cooling to a rectal temperature of 33.5 C using phase changing material in neonatal encephalopathy. Effectiveness will be defined by examining the stability of rectal temperature during cooling. Monitoring of vital signs, infection screen, blood counts, coagulation screen, liver and renal function tests, cranial US and MR imaging will be performed on recruited infants to evaluate safety of cooling. EEG will be performed on day 4 and hearing evaluation at discharge. Neurodevelopmental evaluation will be performed at 1 year of age.

Conditions

  • Hypoxic Ischemic Encephalopathy

Interventions

PROCEDURE

Cooling

Reduction of rectal temperature to 33.5 C

Sponsors & Collaborators

  • Thayyil, Sudhin

    collaborator INDIV

  • Robertson, Nicola, M.D.

    lead INDIV

Principal Investigators

  • Balraj Guhan, MD · Calicut Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-01-31
Completion
2011-08-31

Countries

  • India

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 NCT01138176 on ClinicalTrials.gov