Overview

This trial is active, not recruiting.

Condition hypoxic ischemic encephalopathy
Treatment cooling
Phase phase 1/phase 2
Sponsor Robertson, Nicola, M.D.
Collaborator Thayyil, Sudhin
Start date July 2009
End date January 2011
Trial size 35 participants
Trial identifier NCT01138176, PCM09

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
cooling Therapeutic hypothermia
Reduction of rectal temperature to 33.5 C
(Experimental)
Reduction of rectal temperature to 33.5 C for 72 hours
cooling Therapeutic hypothermia
Reduction of rectal temperature to 33.5 C

Primary Outcomes

Measure
Stability of cooling
time frame: 72 hours

Secondary Outcomes

Measure
Brain tissue injury on MR imaging
time frame: 7 to 10 days
Adverse neurodevelopment
time frame: 12 months
Mortality
time frame: 4 weeks
EEG abnormality
time frame: 4 days
Sepsis
time frame: 1 week

Eligibility Criteria

Male or female participants up to 24 hours old.

Inclusion Criteria: - Apgar score of <5 at 5 minutes or continued resuscitation at 5 minutes - Neonatal encephalopathy Exclusion Criteria: - Imminent death - Major congenital malformations - Gestation <36 weeks - Birthweight less than 1.8 kg

Additional Information

Official title Phase II Randomized Control Trial of Whole Body Cooling in Neonatal Encephalopathy Using Phase Changing Material
Principal investigator Balraj Guhan, MD
Description Meta-analyses of these trials show that therapeutic hypothermia increases survival with normal neurological function (pooled risk ratio of 1.53) with a number needed to treat of 8 (95% confidence interval (CI) 5 - 17) and in survivors reduces the rates of severe disability and cerebral palsy. Therapeutic hypothermia is now widely offered to moderately or severely asphyxiated infants in high-income countries. The global burden of disease estimates indicate that perinatal asphyxia is a very significant problem in low and mid resourced settings. There are, however, several compelling reasons why the efficacy and safety data on therapeutic hypothermia from high-income countries cannot be extrapolated to neonatal units in transitional countries, such as India; in particular there is a lack of effective low tech servo controlled cooling equipments that can be used in these settings. This pilot phase II randomized control trial will examine the efficacy of phase changing material in providing satisfactory therapeutic hypothermia in neonatal encephalopathy, in a mid resource setting.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by Robertson, Nicola, M.D..