Investigating the transmission of drug-resistant bacteria from mothers to infants
Perinatal Transmission of Multi-drug Resistant (MDR) Bacteria
This study looks at how often drug-resistant bacteria are passed from mothers to their newborns to understand its effects on babies' health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | Female |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06148480 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence of extended-spectrum beta-lactamase producing Escherichia coli (ESBL-E) in postpartum women and the rate at which these bacteria are transmitted to their infants. Conducted at Northwestern Medicine Prentice Women's Hospital, the study will involve mothers who deliver vaginally or via scheduled C-section. Researchers will utilize whole genome sequencing and comparative genomics to analyze the genetic relatedness of bacterial strains found in mothers and their infants, testing hypotheses regarding colonization rates and genetic transmission factors. The findings could provide insights into the impact of multi-drug resistant bacteria on neonatal health.
Who should consider this trial
Good fit: Ideal candidates for this study are postpartum women who have delivered vaginally or via scheduled C-section and their healthy infants.
Not a fit: Patients who may not benefit include those with complications during delivery, such as emergency C-sections or those requiring NICU transfer.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of multi-drug resistant infections in newborns, potentially reducing morbidity and mortality associated with these infections.
How similar studies have performed: Other studies have indicated significant rates of perinatal transmission of drug-resistant bacteria, suggesting that this approach is relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women that are admitted to Northwestern Medicine Women's Hospital that have delivered an infant vaginally or have had a scheduled C-section without preceding labor. * Infants that are born vaginally who are healthy and do not require transfer to the NICU for any reason. Exclusion Criteria: * Temperature \>38 Celsius in labor * Caesarean section after labor * Rupture of membranes or done emergently * Antibiotic use in last trimester including for GBS+ * Delivery at \<35 weeks * Immunocompromised host including being HIV+ * Infant requiring transfer to NICU for any reason and infants who are transferred to the NICU.
Where this trial is running
Chicago, Illinois
- Prentice Women's Hospital — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Mehree Arshad, MD — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Mehreen Arshad
- Email: marshad@luriechildrens.org
- Phone: 3122274668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.