Prospective Research in Infants with Mild Encephalopathy

Study ID
STU 122012-047

Cancer Related

Healthy Volunteers

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)
  • Parkland Health & Hospital System

Diana Vasil

Principal Investigator
Lina Chalak, M.D.


To determine the natural history of NE infants who do not qualify for Therapeutic Hypothermia by determing the percent of infants with neurological abnormalities that resolve, persist, or progress during the hospital stay, the percent of thses infants that have an abnormal aEEG performed at less than or equal to 6 hours of age, and to determine the percent of these infants with evidence of brain injury on MRI performed between 7 and 30 days of life.

Participant Eligibility

-infants greater than or equal to 36 weeks gestation and birth weight of greater than or equal to 1800 grams who have evidence of a perinatal event and some degree of neonatal encephalopathy but do not qualify for therapeutic hypothermia.
-Evidence of a perinatal event includes:
-pH less than or equal to 7.0 or a base deficit of greater than or equal to 16 mmol/L in a sample of umbilical cord blood or any blood speciman during the first hour after birth.
-if the pH is between 7.01 and 7.15, or a base deficit is between 10 and 15.9 mmol/L, or a blood gas is not available, additional criteria will be required. These will include an acute perinatal event (e.g. late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest) and either a 10 minute Apgar score of less than or equal to 5 or assisted ventilation initiated at birth and continued for greater than or equal to 10 minutes.
- Modified Sarnat scoring with a mild result, scores in categories adding to less than 3 categories have scores of 2 or 3.