Neonatal sepsis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Pregnant women delivering in our hospital and their newborns (maternal-infant pairs to be enrolled consecutively); 2.Pregnant women with at least one infection-related perinatal risk factor, including but not limited to: (1).Maternal fever during labor (body temperature > 38 °C); (2).Premature rupture of membranes lasting > 18 hours; (3).Positive prenatal screening for Group B Streptococcus (GBS); (4).Clinical diagnosis or high suspicion of chorioamnionitis; 3.Newborns who undergo a complete infection evaluation within 72 hours after birth. Control Group: 1.Pregnant women who delivered at the same hospital during the same period and their newborns, pair-matched with the mother–infant pairs in the case group; 2.Pregnant women have no perinatal infection-related high-risk factors, no maternal fever, no prolonged premature rupture of membranes, negative GBS screening, and no clinical evidence of infection such as chorioamnionitis; 3.Newborns have a negative infection evaluation within 72 hours after birth, with no clinical manifestations or laboratory abnormalities related to early-onset neonatal infection; 4.Matched 1:2 with the case group by maternal age and gestational week at delivery.
Exclusion criteria
Exclusion criteria: 1.Pregnant women with severe chronic infectious diseases requiring long-term or specialized treatment during pregnancy (e.g., HIV infection); 2.Pregnant women who received systemic antimicrobial therapy within 1 week before delivery; 3.Newborns with a confirmed diagnosis of severe structural malformations or genetic/chromosomal abnormalities; 4.Newborns in whom infection occurred more than 72 hours after birth (late-onset sepsis) or whose clinical manifestations could be fully explained by non-infectious diseases; 5. Those with incomplete perinatal or neonatal clinical data, preventing completion of EOS diagnostic evaluation or follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mcf-DNA level; | — |
Countries
China
Contacts
Chongqing Health Center for Women and Children