|Title||Limitations of Conventional Magnetic Resonance Imaging as a Predictor of Death or Disability Following Neonatal Hypoxic-Ischemic Encephalopathy in the Late Hypothermia Trial.|
|Publication Type||Journal Article|
|Year of Publication||2021|
|Authors||Laptook AR, Shankaran S, Barnes P, Rollins N, Do BT, Parikh NA, Hamrick S, Hintz SR, Tyson JE, Bell EF, Ambalavanan N, Goldberg RN, Pappas A, Huitema C, Pedroza C, Chaudhary AS, Hensman AM, Das A, Wyckoff M, Khan A, Walsh MC, Watterberg KL, Faix R, Truog W, Guillet R, Sokol GM, Poindexter BB, Higgins RD|
|Corporate Authors||Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network|
|Date Published||2021 03|
|Keywords||Developmental Disabilities, Female, Humans, Hypothermia, Induced, Hypoxia-Ischemia, Brain, Infant, Infant, Newborn, Infant, Premature, Magnetic Resonance Imaging, Male, Predictive Value of Tests, Severity of Illness Index|
OBJECTIVE: To investigate if magnetic resonance imaging (MRI) is an accurate predictor for death or moderate-severe disability at 18-22 months of age among infants with neonatal encephalopathy in a trial of cooling initiated at 6-24 hours.
STUDY DESIGN: Subgroup analysis of infants ≥36 weeks of gestation with moderate-severe neonatal encephalopathy randomized at 6-24 postnatal hours to hypothermia or usual care in a multicenter trial of late hypothermia. MRI scans were performed per each center's practice and interpreted by 2 central readers using the Eunice Kennedy Shriver National Institute of Child Health and Human Development injury score (6 levels, normal to hemispheric devastation). Neurodevelopmental outcomes were assessed at 18-22 months of age.
RESULTS: Of 168 enrollees, 128 had an interpretable MRI and were seen in follow-up (n = 119) or died (n = 9). MRI findings were predominantly acute injury and did not differ by cooling treatment. At 18-22 months, death or severe disability occurred in 20.3%. No infant had moderate disability. Agreement between central readers was moderate (weighted kappa 0.56, 95% CI 0.45-0.67). The adjusted odds of death or severe disability increased 3.7-fold (95% CI 1.8-7.9) for each increment of injury score. The area under the curve for severe MRI patterns to predict death or severe disability was 0.77 and the positive and negative predictive values were 36% and 100%, respectively.
CONCLUSIONS: MRI injury scores were associated with neurodevelopmental outcome at 18-22 months among infants in the Late Hypothermia Trial. However, the results suggest caution when using qualitative interpretations of MRI images to provide prognostic information to families following perinatal hypoxia-ischemia.
TRIAL REGISTRATION: Clinicaltrials.gov: NCT00614744.
|Alternate Journal||J Pediatr|
|PubMed Central ID||PMC7914162|
|Grant List||KL2 TR003168 / TR / NCATS NIH HHS / United States |
UG1 HD027904 / HD / NICHD NIH HHS / United States
UL1 TR003167 / TR / NCATS NIH HHS / United States
U10 HD027853 / HD / NICHD NIH HHS / United States