Hypoxic-ischemic Encephalopathy Clinical Trial
— NEATOOfficial title:
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study
Verified date | June 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability. Cooling therapy (hypothermia) provides some protection, but about half of affected infants still have a poor outcome. This clinical trial will determine if the drug erythropoietin, given with hypothermia, is safe to use as a treatment that may further reduce the risk of neurologic deficits after HIE.
Status | Completed |
Enrollment | 50 |
Est. completion date | September 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 24 Hours |
Eligibility |
Inclusion Criteria: - Newborns = 36 weeks gestation, < 23 hours of age at time of consent, must meet all 3 Inclusion Criteria to be eligible for the study: 1. Perinatal depression = at least one of the following: a) Apgar =5 at 10 min or b) required resuscitation (endotracheal or mask ventilation, or chest compressions) at 10 min or c) pH < 7.0 or base deficit =15 in cord, arterial, or venous blood obtained at <60 min of age; 2. Moderate to severe encephalopathy = at least 3 of 6 modified Sarnat criteria present between 1-6 h of birth: a) reduced level of consciousness; b) decreased spontaneous activity; c) hypotonia; d) decreased suck; e) decreased Moro reflex; or f) respiratory distress including periodic breathing or apnea; and 3. Hypothermia = passive or active cooling begun by 6 hours of age. Exclusion Criteria: - Intrauterine growth restriction (BW <1800 g); - Major congenital malformation; suspected genetic syndrome, metabolic disorder or TORCH infection; - Head circumference < 2 SD for gestation; - Infant for whom withdrawal of supportive care is being considered; or - Anticipated inability to collect primary endpoint at 12 months of age. |
Country | Name | City | State |
---|---|---|---|
United States | Arkansas Children's Hospital Research Institute | Little Rock | Arkansas |
United States | Stanford University | Palo Alto | California |
United States | Washington University | Saint Louis | Missouri |
United States | UCSF | San Francisco | California |
United States | Kaiser Permanente, Santa Clara | Santa Clara | California |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Arkansas Children's Hospital Research Institute, Children's National Research Institute, Kaiser Permanente, Seattle Children's Hospital, Stanford University, Thrasher Research Fund, Washington University School of Medicine |
United States,
Darrah J, Bartlett D, Maguire TO, Avison WR, Lacaze-Masmonteil T. Have infant gross motor abilities changed in 20 years? A re-evaluation of the Alberta Infant Motor Scale normative values. Dev Med Child Neurol. 2014 Sep;56(9):877-81. doi: 10.1111/dmcn.12452. Epub 2014 Mar 29. — View Citation
Massaro AN, Wu YW, Bammler TK, Comstock B, Mathur A, McKinstry RC, Chang T, Mayock DE, Mulkey SB, Van Meurs K, Juul S. Plasma Biomarkers of Brain Injury in Neonatal Hypoxic-Ischemic Encephalopathy. J Pediatr. 2018 Mar;194:67-75.e1. doi: 10.1016/j.jpeds.2017.10.060. — View Citation
Massaro AN, Wu YW, Bammler TK, MacDonald JW, Mathur A, Chang T, Mayock D, Mulkey SB, van Meurs K, Afsharinejad Z, Juul SE. Dried blood spot compared to plasma measurements of blood-based biomarkers of brain injury in neonatal encephalopathy. Pediatr Res. — View Citation
Mulkey SB, Ramakrishnaiah RH, McKinstry RC, Chang T, Mathur AM, Mayock DE, Van Meurs KP, Schaefer GB, Luo C, Bai S, Juul SE, Wu YW. Erythropoietin and Brain Magnetic Resonance Imaging Findings in Hypoxic-Ischemic Encephalopathy: Volume of Acute Brain Injury and 1-Year Neurodevelopmental Outcome. J Pediatr. 2017 Jul;186:196-199. doi: 10.1016/j.jpeds.2017.03.053. Epub 2017 Apr 26. — View Citation
Wu YW, Bauer LA, Ballard RA, Ferriero DM, Glidden DV, Mayock DE, Chang T, Durand DJ, Song D, Bonifacio SL, Gonzalez FF, Glass HC, Juul SE. Erythropoietin for neuroprotection in neonatal encephalopathy: safety and pharmacokinetics. Pediatrics. 2012 Oct;130(4):683-91. doi: 10.1542/peds.2012-0498. Epub 2012 Sep 24. — View Citation
Wu YW, Goodman AM, Chang T, Mulkey SB, Gonzalez FF, Mayock DE, Juul SE, Mathur AM, Van Meurs K, McKinstry RC, Redline RW. Placental pathology and neonatal brain MRI in a randomized trial of erythropoietin for hypoxic-ischemic encephalopathy. Pediatr Res. — View Citation
Wu YW, Mathur AM, Chang T, McKinstry RC, Mulkey SB, Mayock DE, Van Meurs KP, Rogers EE, Gonzalez FF, Comstock BA, Juul SE, Msall ME, Bonifacio SL, Glass HC, Massaro AN, Dong L, Tan KW, Heagerty PJ, Ballard RA. High-Dose Erythropoietin and Hypothermia for Hypoxic-Ischemic Encephalopathy: A Phase II Trial. Pediatrics. 2016 Jun;137(6). pii: e20160191. doi: 10.1542/peds.2016-0191. Epub 2016 May 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Warner Initial Developmental Evaluation (WIDEA) | A 43-item questionnaire developed and standardized to assess the functional domains of self-care, motor function, communication and social cognition in young children. Self care sub-scale score range 17-68. Mobility score range is 9-36. Communication score range is 13-52. Social Cognition score range is 11-44. Total scale range is 50-200. Higher scores mean higher functioning. Lower scores mean lower functioning. | 12 months | |
Primary | Markers of Organ Function | The investigators will monitor organ function and adverse events until hospital discharge from the neonatal intensive care unit | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | |
Secondary | Alberta Infant Motor Scale (AIMS) | The AIMS consists of 58 items, including 4 positions: prone (21 items), supine (9 items), sitting (12 items), & standing (16 items). Each item is scored as 'observed' or 'not observed'. Total score range is 0-58, scored as percentile ranks after a raw score is obtained and plotted against age at testing, based on validated norms. | 12 months |
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