Skip to content

Ultrasensitive Digital PCR Detection of Maternal MCF-DNA Based on CRISPR/Cas12a for Predicting Early-Onset Neonatal Sepsis

Ultrasensitive Digital PCR Detection of Maternal MCF-DNA Based on CRISPR/Cas12a for Predicting Early-Onset Neonatal Sepsis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123177
Enrollment
Unknown
Registered
2026-04-22
Start date
2026-04-23
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal sepsis

Interventions

EOS group:None
Control group:None

Sponsors

Chongqing Health Center for Women and Children
Lead Sponsor

Eligibility

Sex/Gender
Female

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

MeasureTime frame
mcf-DNA level;

Countries

China

Contacts

Public ContactLihua Kang

Chongqing Health Center for Women and Children

82864898@qq.com+86 23 60354459

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026