Retrospective Cohort Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Pediatr. Nov 8, 2016; 5(4): 358-364
Published online Nov 8, 2016. doi: 10.5409/wjcp.v5.i4.358
Serial physical examinations, a simple and reliable tool for managing neonates at risk for early-onset sepsis
Alberto Berardi, Anna Maria Buffagni, Cecilia Rossi, Eleonora Vaccina, Chiara Cattelani, Lucia Gambini, Federica Baccilieri, Francesca Varioli, Fabrizio Ferrari
Alberto Berardi, Anna Maria Buffagni, Eleonora Vaccina, Chiara Cattelani, Lucia Gambini, Federica Baccilieri, Francesca Varioli, Fabrizio Ferrari, Neonatal Intensive Care Unit, Department of Mother and Child, Policlinic University Hospital, 41124 Modena, Italy
Cecilia Rossi, Neonatal Intensive Care Unit, Department of Obstetric and Pediatric, Arcispedale Santa Maria Nuova, 42121 Emilia, Italy
Author contributions: All authors made substantive intellectual contributions to the published study and approved the current version of the manuscript.
Institutional review board statement: In this study we have no institutional review board statement.
Informed consent statement: All details that might disclose the identity of the subjects under study were omitted or anonymized.
Conflict-of-interest statement: The authors have no conflicts of interest relevant to this article to disclose. No authors received an honorarium, grant, or other form of payment to produce the manuscript.
Data sharing statement: No data were created no data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Alberto Berardi, MD, Neonatal Intensive Care Unit, Department of Mother and Child, Policlinic University Hospital, Avenue del Pozzo, 71, 41124 Modena, Italy. berardi.alberto@policlinico.mo.it
Telephone: +39-059-4224921 Fax: +39-059-4223770
Received: June 8, 2016
Peer-review started: June 14, 2016
First decision: July 29, 2016
Revised: August 6, 2016
Accepted: October 1, 2016
Article in press: October 9, 2016
Published online: November 8, 2016
Processing time: 151 Days and 18.1 Hours
Abstract
AIM

To investigate whether serial physical examinations (SPEs) are a safe tool for managing neonates at risk for early-onset sepsis (EOS).

METHODS

This is a retrospective cohort study of neonates (≥ 34 wks’ gestation) delivered in three high-volume level IIIbirthing centres in Emilia-Romagna (Italy) during a 4-mo period (from September 1 to December 31, 2015). Neonates at risk for EOS were managed according to the SPEs strategy, these were carried out in turn by bedside nursing staff and physicians. A standardized form detailing general wellbeing, skin colour and vital signs was filled in and signed at standard intervals (at age 3, 6, 12, 18, 36 and 48 h) in neonates at risk for EOS. Three independent reviewers reviewed all charts of neonates and abstracted data (gestational age, mode of delivery, group B streptococcus status, risk factors for EOS, duration of intrapartum antibiotic prophylaxis, postpartum evaluations, therapies and outcome). Rates of sepsis workups, empirical antibiotics and outcome of neonates at-risk (or not) for EOS were evaluated.

RESULTS

There were 2092 live births and 1 culture-proven EOS (Haemophilus i) (incidence rates of 0.48/1000 live births). Most newborns with signs of illness (51 out of 101, that is 50.5%), and most of those who received postpartum antibiotics (17 out of 29, that is 58.6%) were not at risk for EOS. Compared to neonates at risk, neonates not at risk for EOS were less likely to have signs of illness (51 out of 1442 vs 40 out of 650, P = 0.009) or have a sepsis workup (25 out of 1442 vs 28 out of 650, P < 0.001). However, they were not less likely to receive empirical antibiotics (17 out of 1442 vs 12 out of 650, P = 0.3). Thirty-two neonates were exposed to intrapartum fever or chorioamnionitis: 62.5% (n = 20) had a sepsis workup and 21.9% (n = 7) were given empirical antibiotics. Among 216 neonates managed through the SPEs strategy, only 5.6% (n = 12) had subsequently a sepsis workup and only 1.9% (n = 4) were given empirical antibiotics. All neonates managed through SPEs had a normal outcome. Among 2092 neonates, only 1.6% (n = 34) received antibiotics; 1.4% (n = 29) were ill and 0.2% (n = 5) were asymptomatic (they were treated because of risk factors for EOS).

CONCLUSION

The SPEs strategy reduces unnecessary laboratory evaluations and antibiotics, and apparently does not worsen the outcome of neonates at-risk or neonates with mild, equivocal, transient symptoms.

Keywords: Sepsis; Group B streptococcus; Intrapartum antibiotic prophylaxis; Newborn; Prevention

Core tip: The management of asymptomatic neonates at-risk for early-onset sepsis (EOS) remains a challenge. Algorithms based on the threshold values of risk factors result in a large number of uninfected newborns being evaluated and treated. In a 4-mo, multicenter retrospective cohort study, we evaluated a strategy based on serial physical examinations (SPEs) instead of sepsis workup. We studied 2092 neonates. Among 216 neonates initially managed through SPEs, only 12 (5.6%) had subsequently a sepsis workup; only 4 (1.9%) were given empirical antibiotics. All neonates had a normal outcome. SPEs is a simple and reliable tool for managing neonates at risk for EOS.