Prospective research on infants with mild encephalopathy: the PRIME study

J Perinatol. 2018 Jan;38(1):80-85. doi: 10.1038/jp.2017.164. Epub 2017 Nov 2.

Abstract

Objective: To determine short-term outcomes of infants with evidence of hypoxia-ischemia at birth and classified as mild neonatal encephalopathy (NE) at <6 h of age.

Study design: Prospective multicenter study. Mild NE was defined as ⩾1 abnormal category in modified Sarnat score. Primary outcome was any abnormality on early amplitude integrated electroencephalogram (aEEG) or seizures, abnormal brain magnetic resonance imaging (MRI) or neurological exam at discharge.

Results: A total of 54/63 (86%) of enrolled infants had data on components of the primary outcome, which was abnormal in 28/54 (52%): discontinuous aEEG (n=4), MRI (n=9) and discharge exam (n=22). Abnormal tone and/or incomplete Moro were the most common findings. MRI abnormalities were confined to cerebral cortex but two infants had basal ganglia and/or thalamus involvement. The 18 to 24 months follow-up is ongoing.

Conclusions: A larger than expected proportion of mild NE infants with abnormal outcomes was observed. Future research should evaluate safety and efficacy of neuroprotection for mild NE.

Trial registration: ClinicalTrials.gov NCT01747863.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Brain / pathology*
  • Canada
  • Electroencephalography*
  • Female
  • Humans
  • Hypothermia, Induced / methods
  • Hypoxia-Ischemia, Brain / diagnosis*
  • Infant, Newborn
  • Magnetic Resonance Imaging
  • Male
  • Neurologic Examination
  • Predictive Value of Tests
  • Prospective Studies
  • Seizures / diagnosis
  • Seizures / etiology*
  • Severity of Illness Index

Associated data

  • ClinicalTrials.gov/NCT01747863