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. 2016 Jul;138(1):e20153756. doi: 10.1542/peds.2015-3756

TABLE 1.

Study Inclusion Criteria

Inclusion Criteria: All 4 Criteria Must Be Met Definition
30–364 d of agea AND Self-explanatory
Well-appearing AND Defined as GCS score of 13–15 OR by description of the attending physician when no GCS score assigned
Temperature <38.3°C AND Defined as no measured temperature ≥38.3°C in the previous 24 h
No history of trauma AND History of trauma not given by caretaker as the reason for seeking medical care. If history of trauma was later provided by caretakers, this was not considered to be a history of trauma for purposes of eligibility
Seeking medical evaluation for 1 of the following symptoms ALTE as defined by the National Institutes of Health17
 (1) ALTE/apnea Vomiting without diarrhea defined as >4 episodes of vomiting in the previous 24 h OR ≥3 episodes of vomiting per 24 h for the previous 48 h
 (2) vomiting without diarrhea
 (3) seizures or seizurelike activity
 (4) soft tissue swelling of the scalp
 (5) bruising
 (6) other nonspecific neurologic symptom not described above, such as lethargy, fussiness, or poor feeding

GCS; Glasgow Coma Scale Score.

a

Children <30 d of age were excluded because the validation of PIBIS was part of a larger study evaluating the use of serum biomarkers to identify brain injury. Because serum biomarkers of brain injury are often abnormal in healthy infants <30 d of age, neonates were excluded from the entire study.