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Home > "B" Clinical Trials Conditions > Body Cooling for Birth Asphyxia in Term Infants  Body Cooling for Birth Asphyxia in Term Infants
Body Cooling for Birth Asphyxia in Term Infants
For Condition: Brain Ischemia,Hypoxia, Brain,Asphyxia,Hypoxic-Ischemic Encephalopathy
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: Acute birth asphyxia is a cause of death and neurological injury. At present, there is no proven treatment; however, studies in animals suggest that brain cooling may protect against brain injury. This large multicenter trial will randomize term infants with a history of problems at delivery and signs of depression to total body cooling or standard care. Eligible infants greater than 36 wks gestation identified less than 6 hours after birth will be randomized and treated for 72 hrs to determine if cooling reduces the risk of death or moderate to severe neurologic disability at 18-22 mos.
Details: Perinatal cerebral hypoxia-ischemia injury is an important cause of death and neurodevelopmental disability. Data from animal models suggest that brain cooling immediately after injury is neuroprotective. Experience with total body cooling during surgery, accidental near drownings, and one Phase I trial of term infants suggest that it is effective and safe in children. This large multicenter trial will test whether cerebral cooling initiated within 6 hrs of birth and continued for 72 hrs will reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 mos. Infants at least 36 weeks gestation with an abnormal blood gas within 1 hr of birth event or a history of an acute perinatal event and a 10-min Apgar score less than 5 or continued need for ventilation will be identified. Those with moderate to severe encephalopathy will be randomized to a 72 hr period of total body cooling (cooling blanket, followed by slow rewarming). The study will be conducted in two phases: Phase I (20 infants) will examine safety of an esophageal temperature of 34-35 C, Phase II (main trial, 200 infants) will evaluate the safety and efficacy of an esophageal temperature of 33-34 C. The primary outcome is death or moderate/severe disability at 18-22 mos of age; secondary outcomes include length of hospital stay, frequency of multi-organ dysfunction; withdrawal of support; post-neonatal deaths; multiple disability; seizure disorders; rehospitalization. The sample size was based on a 50 percent incidence of death or disability (defined as cerebral palsy, Bayley MDI less than 70, deafness or blindness) following moderate to severe encephalopathy in the control group; a 30 percent reduction in the cooled group; 80 percent power; a two-tailed Type 1 error of 0.05; and 10 percent loss to follow up. Cardio-respiratory, EEG, renal,metabolic and hematologic status and esophageal and abdominal skin temperature will be monitored during 72 hours of intervention. Neurodevelopmental outcome will be assessed at 18-22 mos of age by masked certified examiners.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: /6 Hours
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - At least 36 weeks gestation - Any blood gas (cord, postnatal) done within the first 60 minutes had a pH less than or equal to 7.0 - Any blood gas (cord postnatal) done within the first 60 minutes had a base deficit greater than or equal to 16 mEq/L - All infants must have seizures or signs of moderate to severe encephalopathy before randomization Exclusion Criteria: - Inability to randomize by 6 hours of age - Presence of known chromosomal anomaly or major congenital anomaly - Severe intrauterine growth restriction (weight less than 1800g) - All blood gases done within the first 60 minutes had a pH less than 7.15 and a base deficit less than 10 mEq/L - Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist - Parents refuse consent - Attending neonatologist refuses consent
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
SeethaShankaran, Principal Investigator, Wayne State University
University of Miami *Recruiting*
Miami, Florida, 33101
United States
Recruiting Charles Bauer 305-243-6408
Case Western Reserve Univ *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Avroy Fanaroff 216-844-3387
University of Texas *Recruiting*
Houston, Texas,
United States
Recruiting Jon Tyson 713-500-5651
University of Tennessee *Recruiting*
Memphis, Tennessee, 38163
United States
Recruiting Sheldon Korones 901-448-5950
Women and Infants Hospital *Recruiting*
Providence, Rhode Island, 02903
United States
Recruiting William Oh 401-444-5648
Indiana University *Recruiting*
Indianapolis, Indiana, 46202-4716
United States
Recruiting James Lemons 317-274-4716
University of Cincinnati *Recruiting*
Cincinnati, Ohio, 45267-0541
United States
Recruiting Edward Donovan 513-558-0586
Stanford University *Recruiting*
Palo Alto, California, 94304
United States
Recruiting David Stevenson 650-723-5711
University of Alabama *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting Waldemar Carlo 205-934-4680
Emory University *Recruiting*
Atlanta, Georgia, 30335
United States
Recruiting Barbara Stoll 404-616-4962
University of Texas *Recruiting*
Dallas, Texas, 75235
United States
Recruiting Abbot Laptook 214-648-3753
University of New Mexico *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Lu-Ann Papile 505-272-5551
Yale University *Recruiting*
New Haven, Connecticut, 06520
United States
Recruiting Richard Ehrenkranz 203-688-2895
Additional Information:
Study ID Numbers: NICHD-1003; U10 HD34216,U10 HD21397,U10 HD27880,U10 HD21373,U10 HD21385,U10 HD27871,U10 HD27881,U01 HD36790,U10 HD27856,M01 RR00750,U10 HD27853,M01 RR08084,M01 RR00070,M01 RR00997,U10 HD27851,U10 HD21415,U10 HD27904,M01 RR06022
Study Start Date: October 1999
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005772
Other Hypoxic-Ischemic Encephalopathy Studies:
1. Body Cooling for Birth Asphyxia in Term Infants
Related Studies:
Other Hypoxic-Ischemic Encephalopathy Clinical Trials
Other California Clinical Trials
Other Palo Alto Clinical Trials
Body Cooling for Birth Asphyxia in Term Infants
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