Consequences of early-life antibiotic exposure on antimicrobial gene selection: what regimen causes least harm?

Recruiting

• Conditions: (suspected) perinatal infections; infections in newborn; 10019815

• Registration Number: NL-OMON50570
• Lead Sponsor: Spaarne Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 147

Inclusion Criteria

- need for empirical antibiotic treatment within the first week of life
- vaginal birth or birth by emergency caesarean section
- term delivery (defined as born after 36 weeks of gestational age)

Exclusion Criteria

- major known underlying disease.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Short- and long-term prevalence of AMR genes in the microbiome of the<br /><br>gastrointestinal tract in infants exposed to broad-spectrum antibiotics in the<br /><br>first week of life compared to healthy controls.<br /><br>Short- and long-term effects of broad-spectrum antibiotics administered in the<br /><br>first week of life on the composition of the microbiome of the gut in the first<br /><br>year of life compared to controls.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Which of the recommended and generally used broad-spectrum antibiotic regimens<br /><br>for treating neonatal infections induces least AMR gene selection and<br /><br>disturbance of the microbial composition as compared to non-treated control<br /><br>neonates.</p><br>