Prospective research on infants with mild encephalopathy: the PRIME study

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.

Conflict of interest statement

CONFLICT OF INTEREST

The authors declare no conflict of interest.

Figures

Figure 1.

Flowchart of patient enrollment.

Figure 2.

Abnormalities in the modified Sarnat exam and its components over time. The percentage of infants with any abnormality on the modified Sarnat score (mild NE) decreased over time to 28% (15 patients) at discharge. Please, note that in this cohort, seven patients had neurological abnormalities only on the extended exam at discharge and therefore are not included in this figure.