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Published on: October 24, 2019
Group B Streptococcus early-onset disease and observation of well-appearing newborns
Alberto Berardi1, Caterina Spada2, Maria Letizia Bacchi Reggiani3
1Terapia Intensiva Neonatale, Dipartimento Integrato Materno-Infantile, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy.
Insights
Serial physical examinations (SPEs) effectively manage asymptomatic newborns at risk for early-onset disease (EOS), offering a safe alternative to empirical antibiotic therapy and laboratory screening.
Area of Science:
- Neonatal Medicine
- Infectious Disease Epidemiology
- Clinical Practice Guidelines
Background:
- International guidelines lack consensus on managing asymptomatic neonates at risk for early-onset disease (EOS).
- Large newborn cohorts are essential for evaluating management strategies' safety and efficacy.
Purpose of the Study:
- To evaluate the safety and efficacy of serial physical examinations (SPEs) for managing asymptomatic neonates at risk for EOS.
- To compare outcomes before and after implementing SPEs in a regional cohort.
Main Methods:
- Prospective, area-based cohort study in Emilia-Romagna, Italy (2003-2016).
- Compared EOS cases in a baseline period (2003-2009) with an intervention period (2010-2016) using SPEs for at-risk asymptomatic neonates.
- Included over 532,000 live births (LBs).
Main Results:
- A total of 108 EOS cases were identified (60 in baseline, 48 in intervention).
- Neonates exposed to intrapartum antibiotic prophylaxis (IAP) presented earlier with symptoms (median 0-1 hours vs. 6 hours).
- No adverse outcomes occurred due to SPEs, and no severe EOS cases developed after 6 hours of life post-implementation.
Conclusions:
- Serial physical examinations (SPEs) appear safe and effective for asymptomatic newborns at risk for EOS.
- SPEs may be a viable alternative to laboratory screening and empirical antibiotic therapy.
- The risk of EOS in asymptomatic neonates exposed to intrapartum fever was low.
Background:
International guidelines lack a substantial consensus regarding management of asymptomatic full-term and late preterm neonates at risk for early-onset disease (EOS). Large cohorts of newborns are suitable to increase the understanding of the safety and efficacy of a given strategy.
Methods:
This is a prospective, area-based, cohort study involving regional birth facilities of Emilia-Romagna (Italy). We compared cases of EOS (at or above 35 weeks' gestation) registered in 2003-2009 (baseline period: 266,646 LBs) and in 2010-2016, after introduction of a new strategy (serial physical examinations, SPEs) for managing asymptomatic neonates at risk for EOS (intervention period: 265,508 LBs).
Results:
There were 108 cases of EOS (baseline period, n = 60; intervention period, n = 48). Twenty-two (20.4%) remained asymptomatic through the first 72 hours of life, whereas 86 (79.6%) developed symptoms, in most cases (52/86, 60.5%) at birth or within 6 hours. The median age at presentation was significantly earlier in the intrapartum antibiotic prophylaxis (IAP)-exposed than in the IAP-unexposed neonates (0 hours, IQR 0.0000-0.0000 vs 6 hours, IQR 0.0000-15.0000, p<0.001). High number of neonates (n = 531) asymptomatic at birth, exposed to intrapartum fever, should be treated empirically for each newborn who subsequently develops sepsis. IAP exposed neonates increased (12% vs 33%, p = 0.01), age at presentation decreased (median 6 vs 1 hours, p = 0.01), whereas meningitis, mechanical ventilation and mortality did not change in baseline vs intervention period. After implementing the SPEs, no cases had adverse outcomes due to the strategy, and no cases developed severe disease after 6 hours of life.
Conclusions:
Infants with EOS exposed to IAP developed symptoms at birth in almost all cases, and those who appeared well at birth had a very low chance of having EOS. The risk of EOS in neonates (asymptomatic at birth) exposed to intrapartum fever was low. Although definite conclusions on causation are lacking, our data support SPEs of asymptomatic newborns at risk for EOS. SPEs seems a safe and effective alternative to laboratory screening and empirical antibiotic therapy.
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