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Asthma, a disease due to a lack of bacterial infections in childhood.


- candidate number1513
- NTR NumberNTR349
- ISRCTNISRCTN54378178
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-nov-2005
- Secondary IDsNWO-NAF 3.2.93.96.2 
- Public TitleAsthma, a disease due to a lack of bacterial infections in childhood.
- Scientific TitleAsthma, a disease due to a lack of bacterial infections in childhood.
- ACRONYMINDIAAN
- hypothesisThe degree of TH1-skewing by mycobacteria is controlled by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.
- Healt Condition(s) or Problem(s) studiedAtopic disease, Asthma
- Inclusion criteriaHigh-risk newborns. High-risk was defined as either a mother or a father plus a sibling with present or past atopic disease.
- Exclusion criteria1. Maternal infection in the last week of pregnancy;
2. The use of immunomodulatory drugs or antibiotics during pregnancy (mother);
3. The use of antibiotics preinatally (mother and newborn);
4. Prematurity;
5. Signs of intra-uterine infection;
6. Premature rupture of membranes;
7. Presence of congenital disorders of the airways;
8. Sever other congenital disorders;
9. Need for mechanical ventilation;
10. Prolonged administration of extra oxygen;
11. Need for intensive care treatment.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-1999
- planned closingdate1-jul-2005
- Target number of participants120
- InterventionsBCG vaccination or placebo.
- Primary outcomeIncidence and severity of atopic disease at the age of 4 years.
- Secondary outcome1. SCORAD;
2. Lung function;
3. Cytokine production;
4. NRAMP-polymorphisms.
- Timepoints
- Trial web sitehttp://www.kinderallergologie.nl choose: zie Indiaan onderzoek
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. M.O. Hoekstra
- CONTACT for SCIENTIFIC QUERIESDr. M.O. Hoekstra
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Organization for Scientific Research (NWO), Netherlands Asthma Foundation
- PublicationsN/A
- Brief summaryNo effect of BCG vaccination in 6 weeks old high-risk infants on clinical or immunological parameters was observed at the age of 18 months. However, in a post-hoc analysis a beneficial effects was observed in children from non-allergic mothers (i.e. fathers + sibling allergic).
- Main changes (audit trail)
- RECORD9-sep-2005 - 6-mrt-2006


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