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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20850

Enrollment

120

Registered

2005-11-09

Start date

1999-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A randomised single-blinded intervention study in high-risk newborns vaccinated at the age of 6 weeks with BCG or placebo.

Interventions

BCG vaccination or placebo.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Incidence and severity of atopic disease at the age of 4 years.	—

Secondary

Measure	Time frame
1. SCORAD; 2. Lung function; 3. Cytokine production; 4. NRAMP-polymorphisms.	—

Contacts

Public ContactM.O. Hoekstra

University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital, P.O. Box 85090

m.o.hoekstra@umcutrecht.nl+31 (0)30 2504001

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)