search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


ZEBRA study


- candidate number21869
- NTR NumberNTR5119
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mrt-2015
- Secondary IDsM014-024 
- Public TitleZEBRA study
- Scientific TitleConsequences of early-life antibiotic exposure on antimicrobial gene selection: what regimen causes least harm?
- ACRONYMZEBRA
- hypothesis
- Healt Condition(s) or Problem(s) studiedNeonatal sepsis, Antimicrobial resistance, microbiomics
- Inclusion criteria1. Need for empirical antibiotic treatment within the first week of life;
2. Vaginal birth;
3. Term delivery (defined as born after 36 weeks of gestational age).
- Exclusion criteriaMajor known underlying disease
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-nov-2014
- planned closingdate1-nov-2016
- Target number of participants132
- InterventionsThe 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 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).
- Primary outcome1. 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 outcomeTo 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.
- TimepointsSamples will be collected 5 times during the first year of life from each participant, either in the clinic or at home.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Marta Reyman
- CONTACT for SCIENTIFIC QUERIES Marta Reyman
- Sponsor/Initiator Linnaeus Institute
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)23-dec-2015:
Inclusion NEW:
2. Vaginal birth or birth by emergency caesarean section

Interventions NEW:
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).
- RECORD26-mrt-2015 - 23-dec-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl