An open label randomized controlled trial to assess the role of serial physical examination for asymptomatic neonates ≥ 35 weeks gestation at risk of early onset sepsis

Summary:

· Background- Early onset sepsis (EOS, sepsis occurring from 0 to 72 h of life) remains a serious and potentially fatal illness. In full-term neonates EOS is usually caused by vertical transmission of organisms present in the birth canal during labour. Mothers with risk factors may give birth to neonates who may have increased probability of developing EOS. However, associations between each individual risk factor and EOS are weak, particularly in the era of maternal GBS screening and intrapartum antibiotic prophylaxis (IAP) for preventing EOS. In addition, consideration of the clinical status of the neonate in the overall risk assessment is critical, with the risk of EOS in neonates who appear well at birth reduced by approximately 60–70%. Therefore, guidelines for prevention of EOS based on risk factors alone, and not incorporating the clinical exam, have resulted in unnecessary evaluations, maternal–infant separation, longer length of hospital stay, delayed breastfeeding, and antibiotic exposure in numerous well appearing uninfected neonates 1. Antibiotic use in the newborn period is not without potential harm, since it may promote the emergence of resistant pathogens or disrupt the development of the intestinal microbiome with potential long-term implications.

Our study aims to reduce the administration of antibiotic therapy and unnecessary investigations which involve skin pricks, by clinically observing and non-invasive monitoring of vital parameters of the well appearing asymptomatic baby who is at-risk of EOS.

 Â· Methods: The trial will be done on asymptomatic neonates, who has risk-factors for developing EOS by assessing eligibility followed by randomization of the baby in either

o Comparator group- where conventional management by sending laboratory investigations for sepsis followed by starting antibiotic therapy without awaiting results will be followed.

o Intervention group- where the babies will be monitored clinically and by non-invasive parameters (serial physical examination, SPE), from the first hour of life, at specific time intervals, upto 48 hours of life. If in this duration, the baby’s clinical status worsens, only then the baby will be evaluated by sending sepsis workup and started on antibiotics immediately, without waiting for results. If the baby is clinically fine, then the baby will not be investigated for sepsis, or started on antibiotics.

· Discussion: Implementing SPE to guide empiric antibiotic therapy in asymptomatic neonates with risk factors for EOS has been studied to have reduced significantly the burden of antibiotic exposure and laboratory investigations, without delay of antibiotic treatment of infected neonates or increased risk of sepsis-related complications or mortality. SPE strategy may require changes in the protocols of newborn care at birthing units. Nonetheless, it is a safe practice related which will benefit any mother and child unit.

Recriutment status: Currently we have recruited 54 cases in total. No adverese event in any case.