Cool Prime Comparative Effectiveness Study for Mild HIE

Description

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.

Conditions

Mild Hypoxic Ischemic Encephalopathy of Newborn

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Study Overview

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Study Details

Study overview

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.

COOLPRIME: Comparative Effectiveness for Cooling Prospectively Infants With Mild Encephalopathy

Cool Prime Comparative Effectiveness Study for Mild HIE

Condition
Mild Hypoxic Ischemic Encephalopathy of Newborn
Intervention / Treatment

-

Contacts and Locations

Atlanta

EMORY University Hospital, Atlanta, Georgia, United States, 30322

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 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 dystocia
  • 6. Any evidence suggestive of acute perinatal event.
  • 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

Ages Eligible for Study

35 Weeks to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Lina Chalak, MD, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

2029-01-01