No registrations found.
ID
Source
Brief title
Health condition
Neonates suspected of infection, microbiome, antibiotic resistance
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
-
Study objective
-
Study design
Samples will be collected 5 times during the first year of life from each participant, either in the clinic or at home.
Intervention
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 born by emergency caesarean section who will be recruited prenatally and followed in parallel through home-visits, receiving no antibiotics in the first week of life (MUIS study, M012-015, NTR3986).
Marta Reyman
Postbus 770
Hoofddorp 2130 AT
The Netherlands
+31 (0)23 8909070
ZEBRA@spaarneziekenhuis.nl
Marta Reyman
Postbus 770
Hoofddorp 2130 AT
The Netherlands
+31 (0)23 8909070
ZEBRA@spaarneziekenhuis.nl
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
Major known underlying disease
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4882 |
| NTR-old | NTR5119 |
| Other | - : M014-024 |