Results of a strategy based on clinical observation of newborns at risk of early-onset neonatal sepsis.

Background: Serial clinical observation of asymptomatic newborns at risk of early-onset sepsis is an alternative option for which there is limited scientific evidence.

Aims: To evaluate the rate of protocol compliance, the impact on blood tests, percentage of hospitalizations and subsequent procedures, and course of diagnosed early-onset sepsis cases of a protocol based on serial clinical observation.

Methods: Retrospective observational study comparing an 18-month period under this protocol against a previous protocol based on laboratory tests.

Subjects: 6895 asymptomatic newborns with over 35 weeks of gestation.

Outcome Measures: number of evaluations performed on each subject at risk, percentage of patients undergoing blood draws and hospitalization rates.

Results: Some of the evaluations included in the protocol were omitted in 51.6 % of the newborns undergoing the physical examinations. The implementation of this new approach was associated with a decrease in the percentage of patients undergoing blood draws from 16.8 % to 0.7 % (p < 0.001) with no differences in the progression of the five cases of sepsis studied in each period. The serial clinical observation protocol was associated with a significant increase in hospitalizations for suspected infection, although with no difference in the rate of lumbar punctures performed or antibiotic treatments administered.

Conclusion: Compliance with the serial clinical observation protocol can be difficult. This approach often detects newborns with abnormal clinical data that are not explained by early-onset sepsis. Clinical observation is a safe option that minimizes the rate of blood draws.