Cool Prime Comparative Effectiveness Study for Mild HIE

Not Recruiting

Trial ID: NCT04621279


To determine effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his/her family. Determine heterogeneity of the treatment effect across key subgroups obtained in the first 6 hours after birth prior to the decision to initiate therapy.

Official Title

COOLPRIME: Comparative Effectiveness for Cooling Prospectively Infants With Mild Encephalopathy


Inclusion Criteria:

Infants must meet all 3 inclusion criteria

   1. Neonates born at ≥ 35 0/7 weeks

   2. Mild Encephalopathy on neonatal neurologic exam within 6 hours after birth: defined as
   presence of at least 2 signs of mild, moderate, or severe encephalopathy with no more
   than 2 signs in the moderate or severe category.

   3. Perinatal Acidosis based on at least one of the following (A or B):

      1. pH ≤ 7.00 in any cord or first infant gas (arterial, venous, or capillary) within
      ≤ 60 min OR base deficit ≥ 16 in any cord or first infant gas (arterial, venous
      or capillary) within ≤ 60 min

      2. If pH is between 7.01 and 7.15, OR base deficit is between 10 and 15.9
      mmol/liter, OR blood gas is not available, an acute perinatal event is an
      additional criteria required (see below definition)

An acute perinatal event is defined by at least one of the following:

   1. Apgar score at 10 min ≤ 5

   2. Continued need for resuscitation at 10 min (chest compressions, bag mask ventilation,
   or positive pressure ventilation)

   3. Uterine rupture, placental abruption, cord accident (prolapse, rupture, knot or tight
   nuchal cord)

   4. maternal trauma, maternal hemorrhage, or cardiorespiratory arrest

   5. fetal exsanguination from either vasa previa or feto-maternal hemorrhage, shoulder

   6. Any evidence suggestive of acute perinatal event.

Infants are still eligible for enrollment in the COOLPRIME study if the cord or infant's
first blood gas (arterial, venous, or capillary) is obtained >60 minutes of life.

Exclusion Criteria:

   1. Gestational age at birth < 35 0/7 weeks

   2. Birth weight < 1800gm

   3. Head circumference <30cm

   4. Congenital or chromosomal anomaly associated with abnormal neurodevelopment or death

   5. Moderate or Severe HIE of 3 or more moderate or severe abnormalities on COOLPRIME
   Sarnat exam within 6 hours of life

   6. Any seizures within first six hours of life

   7. Redirection of care is being considered


procedure: Normothermia

procedure: Whole body therapeutic hypothermia

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305