Asthma: a disease due to a lack of bacterial infections in childhood

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN54378178
• Date of registration: 20/12/2005
• Primary sponsor: University Medical Centre Utrecht (UMCU) (Netherlands)
• Public title: Asthma: a disease due to a lack of bacterial infections in childhood INDIAAN
• Date of first enrolment: Jan 1 1999
• Target sample size: 120
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN54378178
• Study type: Interventional
• Study design: Randomised, single blind, placebo controlled, parallel group trial

Countries of recruitment

Netherlands

Contacts

• Name: M O Hoekstra

Key inclusion & exclusion 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: 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 prenatally (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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Atopic disease, asthma

Intervention(s)

BCG vaccination or placebo.

Primary Outcome(s)

Incidence and severity of atopic disease at the age of 4 years.

Secondary Outcome(s)

1. SCORing Atopic Dermatitis (SCORAD)
2. Lung function
3. Cytokine production
4. Natural Resistance Associated Macrophage Protein (NRAMP) polymorphisms

Secondary ID(s)

NWO-NAF 3.2.93.96.2

Source(s) of Monetary Support

1. The Netherlands Organization for Scientific Research (NWO) (The Netherlands) 2. Netherlands Asthma Foundation (The Netherlands)

Secondary Sponsor(s)

N/A