Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT04621279

Conditions

Mild Hypoxic Ischemic Encephalopathy of Newborn

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Normothermia

Whole body therapeutic hypothermia

Study Details

Brief summary:

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

Study ID

NCT04621279

Start date

Jul 19, 2023

Status verified date

Apr, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Infants must meet all 3 inclusion criteria

1. Neonates born at ≥ 36 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 dystocia
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 < 36 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

Study Design

Enrollment

460 participants

Anticipated

Interventions and Outcome Measures

Arms

Mild HIE

Mild HIE identified in the first 6 hours of life according to the published PRIME study definition: newborn with evidence of encephalopathy (using the validated Sarnat Exam) NOT meeting prior cooling trials criteria.

Interventions

Normothermia

Usual care for first 72 hours for neonates with mild encephalopathy maintaining core temperature (36.5°C ± 1 C).

Whole body therapeutic hypothermia

Whole-body therapeutic hypothermia (33.5°C ± 0.5°C) for 72 hours began by 6 hours of age for neonates with mild encephalopathy per site standard of care practice.

Primary outcome measure

  • Effectiveness of normothermia in infants as measured by Composite Bayley IV score [ Time Frame: 22-26 months of age. ]

Central Contacts and Locations

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75208

Contacts

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • mild HIE (Hypoxic Ischemic Encephalopathy)
  • neonatal encephalopathy
  • brain ischemia
  • brain hypoxia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-05-05.