Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.kinderallergologie.nl

Contact information

Type

Scientific

Primary contact

Dr M O Hoekstra

ORCID ID

Contact details

University Medical Centre Utrecht
Wilhelmina Children's Hospital
P.O. Box 85090
Utrecht
3508 AB
Netherlands
+31 (0)30 250 4001
m.o.hoekstra@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NWO-NAF 3.2.93.96.2

Study information

Scientific title

Acronym

INDIAAN

Study hypothesis

The degree of TH1-skewing by mycobacteria is controlled by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, single blind, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Atopic disease, asthma

Intervention

BCG vaccination or placebo.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/01/1999

Overall trial end date

01/07/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

01/01/1999

Recruitment end date

01/07/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht
Utrecht
3508 AB
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Charity

Funder name

The Netherlands Organization for Scientific Research (NWO) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Asthma Foundation (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes