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ZEBRA study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21464
Enrollment
132
Registered
2015-03-26
Start date
2014-11-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Neonates suspected of infection, microbiome, antibiotic resistance

Interventions

The three most common antibiotic strategies used in the Netherlands will be tested for side-effects on the microbial flora. A control Group will be composed of 44 vaginally born infants or infants bor

Sponsors

Linnaeus Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Need for empirical antibiotic treatment within the first week of life; 2. Vaginal birth or birth by emergency caesarean section; 3. Term delivery (defined as born after 36 weeks of gestational age).

Exclusion criteria

Exclusion criteria: Major known underlying disease

Design outcomes

Primary

MeasureTime frame
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. 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

MeasureTime frame
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.

Contacts

Public ContactMarta Reyman

Spaarne Gasthuis

ZEBRA@spaarneziekenhuis.nl+31 (0)23 8909070

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)