Trial Search Results

Preemie Hypothermia for Neonatal Encephalopathy

This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly assign them to either receive hypothermia or participate in a non-cooled control group.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

NICHD Neonatal Research Network

Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Stanford Investigator(s):

Intervention(s):

  • Device: Hypothermia
  • Procedure: Normothermic Control

Phase:

Phase 2/Phase 3

Eligibility


Inclusion Criteria:

   - Infants 33 0/7 to 35 6/7 weeks GA (best obstetrical estimate)

   - Infants weight greater than or equal to 1500 grams at birth

   - Postnatal age less than 6 hours

   - Infants who meet clinical, biochemical and neurologic criteria for moderate to severe
   NE:

Biochemical: Cord gas or blood gas within first hour of life with pH ≤7.00 or base deficit
(BD) ≥16 mEq/L OR

Acute perinatal event (e.g., abruptio placenta, cord prolapse, uterine rupture, severe FHR
abnormality such as variable or late decelerations) AND Requirement for positive pressure
ventilation for apnea or poor respiratory effort since birth for at least 10 minutes OR 10
minute Apgar score ≤5

AND

Neurologic:

Seizures OR modified Sarnat score with abnormalities in at least 3 of the 6 categories; at
least one must be altered level of consciousness (lethargy or stupor/coma) as determined by
a certified examiner (All infants who meet criteria for potential inclusion will undergo
standard neurologic exam as for infants ≥36 wks GA being considered for hypothermia, with
findings recorded)

Exclusion Criteria:

   - Receipt of sedative, analgesic or paralytic agent that may confound the qualifying
   neurologic exam

   - Etiology of NE not likely to be hypoxic-ischemic in origin

   - Major congenital anomaly that may confound outcome

   - Considered to be moribund and will not be receiving full intensive care

   - Equipment and/or appropriate staff not available

   - Core temperature < 33.5oC for more than one hour at time of screening

   - Unable to randomize by 6 hours of age

   - Infant needs ECMO

   - All blood gases (cord and postnatal at < 1hr of age) have a pH > 7.15 AND a base
   deficit < 10mEq/L

Ages Eligible for Study

33 Weeks - 35 Weeks

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Krisa P. Van Meurs, MD
650-723-5711
Recruiting