Using antibiotics to treat early onset neonatal sepsis
Efficacy and Safety of Antibiotics in the Treatment of Early Onset Neonatal Sepsis
This study is testing different antibiotic treatments for newborns with early onset sepsis to see which ones work best and are safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 0 Days to 3 Days |
| Sex | All |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT03932123 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the efficacy and safety of various antibiotic regimens for treating early onset neonatal sepsis, a serious condition affecting newborns. The study focuses on the use of antibiotics such as piperacillin and tazobactam, azlocillin, and meropenem, among others, in accordance with international guidelines. By analyzing the outcomes of these treatments, the study aims to improve clinical practices in regions where current guidelines are not being followed. Parental consent is required for participation, and the study will include newborns aged 72 hours or younger who meet specific criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns aged 72 hours or younger who meet the NICE guidelines for antibiotic treatment of early onset neonatal sepsis.
Not a fit: Patients who are expected to have a survival time less than the treatment cycle or have major congenital malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for early onset neonatal sepsis, enhancing survival rates and outcomes for affected newborns.
How similar studies have performed: Other studies have shown success with similar antibiotic approaches for treating neonatal sepsis, indicating that this study builds on established practices.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: postnatal age ≤ 72h; * Meets NICE guidelines for using antibiotics to treat EONS; * Azlocillin used as part of antimicrobial treatment; * Parental written consent. Exclusion Criteria: * Expected survival time less than the treatment cycle; * Major congenital malformations; * Undergoing surgery within the first week of life; * Receiving other systemic trial drug therapy; * Other factors that the researcher considers unsuitable for inclusion.
Where this trial is running
Tianjin, Tianjin
- Tianjin Central Hospital of Gynecology Obstetrics — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Wei Zhao, Ph.D
- Email: zhao4wei2@hotmail.com
- Phone: 86053188383308
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.