Cool Prime Comparative Effectiveness Study for Mild HIE
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age36+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Neonates born at ≥ 36 0/7 weeks
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.
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
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)
Disqualifiers
Gestational age at birth < 36 0/7 weeks
Birth weight < 1800gm
Head circumference <30cm
Congenital or chromosomal anomaly associated with abnormal neurodevelopment or death
Trial population
Term infants ≥ 36 weeks' gestation with evidence of both perinatal event fetal acidosis and encephalopathy on exam.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Normothermia
Procedure/SurgeryUsual care for first 72 hours for neonates with mild encephalopathy maintaining core temperature (36.5°C ± 1 C).
Whole body therapeutic hypothermia
Procedure/SurgeryWhole-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.
Treatment groups
460 Participants
are divided into 1 treatment groupGroup A: Mild HIE2 interventions
Trial outcomes
Primary outcomes
1
Effectiveness of normothermia in infants as measured by Composite Bayley IV score
Effectiveness of normothermia in infants is measured by Composite Bayley IV score scale, which is. an extensive formal developmental assessment tool for diagnosing developmental delays in early childhood. Possible scores range from 55- 120 where lower scores indicate worse outcome.
Time frame
22-26 months of age.Secondary outcomes
1
Adverse events SAE
Safety will be measured by the presence or absence of a serious adverse event (SAE) at discharge.
Time frame
Discharge (approximately 7 days)2
Parent-Infant stress and bonding as measured by MIBS
Parent-Infant stress and bonding is measured by Mother-to-infant bonding (MIBS) scale, which is a validated questionnaire with good psychometric properties that assesses the mother's feelings towards infant (bondedness) from birth to 4 months. Possible scores range from 0-3, where 0 indicates "not at all" and 3, "very much".
Time frame
3-4 months3
Parent-Infant stress and bonding as measured by IBQR
Parent-Infant stress and bonding is measured by Infant Behavior Questionnaire-Revised (IBQR) which measures differences in reactivity and regulation, and the structure of infant temperament and its relation to parental family functioning. Item scores were summed according to IBQR scoring rules to create scores on the 14 scales, with higher scores indicating greater levels of that temperament dimension.
Time frame
3-4 months4
Parent-Infant stress and bonding as measured by PSI
Parent-Infant stress and bonding is measured by Parenting Stress Index (PSI) which is an abbreviated version of the full-length test with 36 items in three domains (Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child) that combine to form a Total Stress scale, which helps identify families that are most in need of support services. In general, items are scored using the following 5-point scale: 1) SA (Strongly Agree), 2) A (Agree), 3) NS (Not Sure), 4) D (Disagree), 5) SD (Strongly Disagree). Responses to both the overall stress score and the three subscales are summed to generate representative scores, resulting the total stress score, perceptions of child behavioral problems, parenting distress, and parent-child dysfunctional interactions.
Time frame
3-4 monthsOther outcomes
1
Infant neurological integrity as measured with HNNE
Infant neurological integrity is measured with HNNE (Hammersmith Neonatal Neurological Exams), which is used to assess tone, spontaneous movements, reflexes, and visual and auditory attention allowing for a continuum of assessment from birth to 2 years. The maximum score for any one item is a score of 3 and the minimum is a score of 0. A subscore can be given for each section and the overall global score can be calculated by summing up all 26 items (range: 0-78), with higher scores indicating better neurological performance. The maximum global score is 78.
Time frame
Discharge2
Infant neurological integrity as measured with HINE
Infant neurological integrity is measured with HINE (Hammersmith Infant Neurological Exams), which is used to assess tone, spontaneous movements, reflexes, and visual and auditory attention allowing for a continuum of assessment from birth to 2 years. The maximum score for any one item is a score of 3 and the minimum is a score of 0. A subscore can be given for each section and the overall global score can be calculated by summing up all 26 items (range: 0-78), with higher scores indicating better neurological performance. The maximum global score is 78.
Time frame
3 - 4 months3
Infant neurological integrity as measured with HINE
Infant neurological integrity is measured with HINE (Hammersmith Infant Neurological Exams), which is used to assess tone, spontaneous movements, reflexes, and visual and auditory attention allowing for a continuum of assessment from birth to 2 years. The maximum score for any one item is a score of 3 and the minimum is a score of 0. A subscore can be given for each section and the overall global score can be calculated by summing up all 26 items (range: 0-78), with higher scores indicating better neurological performance. The maximum global score is 78.
Time frame
22-26 months4
Behavioral tendency CBCL
The Child Behavior Checklist-parent report (CBCL) will provide a profile of behavior and social functioning validated in relation to age and gender.
Time frame
22-26 months of age.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
University of California, San Francisco
Collaborator
Children's National Research Institute
Collaborator
Children's Hospital Los Angeles
Collaborator
St. Louis University
Collaborator
Stanford University
Collaborator
University of Utah
Collaborator
University of Pittsburgh Medical Center
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator
University College Cork
Collaborator
The Children's Hospital of San Antonio
Collaborator
Harvard University
Collaborator
Washington University School of Medicine
Collaborator
Sharp HealthCare
Collaborator
The Cleveland Clinic
Collaborator
University of Florida Health
Collaborator
Emory University
Collaborator
Nationwide Children's Hospital
Collaborator
Children's Hospital of Orange County
Collaborator
Parkland Health and Hospital System
Collaborator
Source ClinicalTrials.gov