David K. Stevenson, M.D.
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants greater than or equal to 36 weeks gestational age with hypoxic-ischemic encephalopathy will reduce the incidence of death or disability at 18-24 months of age. The study will enroll 168 infants with signs of hypoxic-ischemic encephalopathy at 16 NICHD Neonatal Research Network sites, and randomly assign them to either receive hypothermia or participate in a non-cooled control group.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Procedure: hypothermia
Phase:
Phase 2/Phase 3Eligibility
Ages Eligible for Study:
6 hours to 24 hoursGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
? Gestational age greater than or equal to 36 weeks at birth
? Postnatal age between 6 and 24 hours
Infants with a high probability of acute hemodynamic compromise, such as those with:
? An acute perinatal event (abruptio placenta, cord prolapse, severe FHR abnormality)
? An Apgar score less than or equal to 5 at 10 minutes
? Need for ventilation initiated at birth and continued for at least 10 minutes
? Cord pH or first postnatal blood gas pH at within 1 hour of less than or equal to 7.0
? Base deficit on cord gas or first postnatal blood gas at less than or equal to 1 hour of greater than or equal to 16 mEq/L
Infants meeting the above criteria who also have an abnormal neurological exam showing the presence of moderate or severe encephalopathy
Key Exclusion Criteria:
* Core body temperature (axilla, rectal) less than 34.0?C for greater than 1 hour
* Presence of a known anomaly or chromosomal aberration
* Birth weight < 1,800 grams
* Infant in extremis
* Refusal of parents or attending physician
Additional Study Details
Official Title:
Evaluation of Systematic Hypothermia Initiated After 6 Hours of Age in Infants greater than or equal to 36 Weeks Gestation with Hypoxic-Ischemic Encephalopathy: A Bayesian EvaluationAnticipated start date:
4/16/2008Lead Sponsor:
NICHDCollaborator(s):
- NICHD Neonatal Research Network
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Death or moderate or severe disability at 18-24 months
Secondary Outcomes:
- Number of deaths in the NICU and following discharge
- Number of infants with moderate and severe disability
- Number of infants with mild, moderate and severe disability
- Number of infants with any disability based on level of encephalopathy at randomization
- Number of infants with non-CNS organ system dysfunction
- Number of infants with a DNR order
- Number of infants with a DNR order and support is withdrawn
- Number of infants with a DNR order and either die or survive
- Number of infants with neonatal seizures, with and without EEG abnormalities
Total Number to be Enrolled:
168Total Number to be Enrolled at Stanford:
10More Information
Publications About this Study:
- 16221780: Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy.
Secondary ID(s):
- NCT00614744
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
4/24/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help