No registrations found.
ID
Source
Brief title
Health condition
A randomised single-blinded intervention study in high-risk newborns vaccinated at the age of 6 weeks with BCG or placebo.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence and severity of atopic disease at the age of 4 years.
Secondary outcome
1. SCORAD;
2. Lung function;
3. Cytokine production;
4. NRAMP-polymorphisms.
Background summary
No 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).
Study objective
The degree of TH1-skewing by mycobacteria is controlled by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.
Intervention
BCG vaccination or placebo.
Wilhelmina Children's Hospital,
P.O. Box 85090
M.O. Hoekstra
Lundlaan 6
Utrecht 3508 AB
The Netherlands
+31 (0)30 2504001
m.o.hoekstra@umcutrecht.nl
Wilhelmina Children's Hospital,
P.O. Box 85090
M.O. Hoekstra
Lundlaan 6
Utrecht 3508 AB
The Netherlands
+31 (0)30 2504001
m.o.hoekstra@umcutrecht.nl
Inclusion criteria
High-risk newborns. High-risk was defined as either a mother or a father plus a sibling with present or past atopic disease.
Exclusion criteria
1. 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.
Design
Recruitment
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 | NL311 |
| NTR-old | NTR349 |
| Other | : NWO-NAF 3.2.93.96.2 |
| ISRCTN | ISRCTN54378178 |