The degree of TH1-skewing by mycobacteria is controlled by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.
Bron
Verkorte titel
Aandoening
A randomised single-blinded intervention study in high-risk newborns vaccinated at the age of 6 weeks with BCG or placebo.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Incidence and severity of atopic disease at the age of 4 years.
Achtergrond van het onderzoek
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).
Doel van het onderzoek
The degree of TH1-skewing by mycobacteria is controlled by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.
Onderzoeksproduct en/of interventie
BCG vaccination or placebo.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
High-risk newborns. High-risk was defined as either a mother or a father plus a sibling with present or past atopic disease.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL311 |
NTR-old | NTR349 |
Ander register | : NWO-NAF 3.2.93.96.2 |
ISRCTN | ISRCTN54378178 |