ZEBRA study
Recruiting
- Conditions
- eonates suspected of infection, microbiome, antibiotic resistance
- Registration Number
- NL-OMON21464
- Lead Sponsor
- innaeus Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 132
Inclusion Criteria
1. Need for empirical antibiotic treatment within the first week of life;
2. Vaginal birth or birth by emergency caesarean section;
Exclusion Criteria
Major known underlying disease
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess the short- and long-term prevalence of AMR genes in the microbiome of the gut in infants exposed to broad-spectrum antibiotics in the first week of life compared to controls.<br /><br>2. To investigate the short- and long-term effects of broad-spectrum antibiotics administered in the first week of life on the composition of the microbiome of the gut in the first 5 years of life compared to controls.
- Secondary Outcome Measures
Name Time Method To identify which of the recommended and generally used broad-spectrum antibiotic regimens for treating neonatal infections induces least AMR gene selection and disturbance of the microbial composition as compared to non-treated control neonates.