RECRUITING

Cool Prime Comparative Effectiveness Study for Mild HIE

Conditions

Mild Hypoxic Ischemic Encephalopathy of Newborn mild HIE (Hypoxic Ischemic Encephalopathy)neonatal encephalopathy brain ischemia brain hypoxia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

COOLPRIME: Comparative Effectiveness for Cooling Prospectively Infants With Mild Encephalopathy

Quick Facts

Study Start:2023-07-19

Study Completion:2029-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04621279

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.

Ages Eligible for Study:35 Weeks

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Lina Chalak, MD

CONTACT

214-648-3903

lina.chalak@utsouthwestern.edu

Pollieanna Sepulveda, MSN, RN

CONTACT

214-648-3698

pollieanna.sepulveda@utsouthwestern.edu

Principal Investigator

Lina Chalak, MD

PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Study Locations (Sites)

EMORY University Hospital

Atlanta, Georgia, 30322

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75208

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-19

Study Completion Date2029-01-01

Study Record Updates

Study Start Date2023-07-19

Study Completion Date2029-01-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Mild Hypoxic Ischemic Encephalopathy of Newborn