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)


Onderzoek microbioom gezonde kinderen.


- candidate number14862
- NTR NumberNTR3986
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-mei-2013
- Secondary IDsM012-M015 
- Public TitleOnderzoek microbioom gezonde kinderen.
- Scientific TitleMicrobiome healthy infant study.
- ACRONYMMUIS
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedHealthy children, Microbiome, Delivery mode, Computer-tailoring
- Inclusion criteria1. Term neonates;
2. Born in the region of Groot Kennemerland and bollenstreek (draining on Spaarne hospital Hoofddorp or Kennemer Gasthuis Haarlem).
- Exclusion criteria1. Severe perinatal/ neonatal/ maternal complications as asphyxia, resuscitation, transfer to neonatal intensive care unit etc;
2. Major congenital anomalies;
3. Language barrier;
4. Intention to move outside the research area;
5. Parents under the age of 18 years.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-sep-2012
- planned closingdate1-sep-2014
- Target number of participants100
- InterventionsObservational prospective cohort study. The development of the infant microbiome during the first 12 months of life and the potential differences in the microbial composition between infants born vaginally and by caesarean section will be studied.
- Primary outcome1. Comparison of the composition of infant microbiome between infants born vaginally and infants born by caesarean section at several time points during the first 12 months of life;
2. The dynamics of the infant nasopharyngeal and oral microbiome in periods of respiratory infections.
- Secondary outcome1. The relation between nasopharyngeal, oral, gastrointestinal and skin microbiome;
2. The dynamics of the infant microbiome in periods of antibiotic consumption;
3. Comparison of the composition of the maternal microbiome and the infant microbiome;
4. Comparison of the composition of the infant microbiome between breastfed infants and formula fed infants;
5. The dynamics of the infant microbiome in case of eczema/atopic diseases;
6. The dynamics of the infant microbiome related to exposure (siblings, day care).
- Timepoints11 home visits during the first year of life and a maximum of 3 extra home visits in case of episodes of respiratory tract infection.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Astrid Bosch
- CONTACT for SCIENTIFIC QUERIES Astrid Bosch
- Sponsor/Initiator Linnaeus Institute
- Funding
(Source(s) of Monetary or Material Support)
Wetenschapsbureau Linneaus instituut Hoofddorp
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD7-mei-2013 - 22-mei-2013


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