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

Consequences of early-life antibiotic exposure on antimicrobial gene selection: what regimen causes least harm? - ZEBRA study (Zuigelingen En Bacteriele Resistentie na Antibiotica)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50570
Enrollment
147
Registered
2015-03-17
Start date
2015-01-16
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

(suspected) perinatal infections

Interventions

None listed

Sponsors

Spaarne Gasthuis
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

Exclusion criteria: - major known underlying disease.

Design outcomes

Primary

MeasureTime frame
Short- and long-term prevalence of AMR genes in the microbiome of the gastrointestinal tract in infants exposed to broad-spectrum antibiotics in the first week of life compared to healthy controls. 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 year of life compared to controls.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)