Table 3.

Protocol deviations and adverse events

Event	n (%)
Deviations	N=96
aEEG recording not performed according to schedule	76 (79%)
Inaccessible	19 (25%)
Too ill	28 (37%)
Equipment malfunction	9 (12%)
Research personnel not available	5 (7%)
Unable to obtain acceptable impedance	2 (3%)
Other	13 (17%)
Incomplete recording performed (<6 hours)	18 (19%)
aEEG data lost prior to transfer	1 (1%)
Other	1 (1%)
Adverse events	N=6*
Skin breakdown (all self-resolved)	3
Skin infection of scalp/head at electrode site	0
Medical device event	0
Other event possibly related to aEEG	3
Cold Stress	1
Desaturation≠	1
Other (inadvertent hair removal by aEEG sensor)	1

^*Number of infants experiencing adverse events and number of reported events were the same

^≠Desaturation event deemed not likely attributable to study intervention