Asthma: a disease due to a lack of bacterial infections in childhood
| ISRCTN | ISRCTN54378178 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54378178 |
| ClinicalTrials.gov number | NCT00200928 |
| Secondary identifying numbers | NWO-NAF 3.2.93.96.2 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 15/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M O Hoekstra
Scientific
Scientific
University Medical Centre Utrecht
Wilhelmina Children's Hospital
P.O. Box 85090
Utrecht
3508 AB
Netherlands
| Phone | +31 (0)30 250 4001 |
|---|---|
| m.o.hoekstra@umcutrecht.nl |
Study information
| Study design | Randomised, single blind, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Asthma: a disease due to a lack of bacterial infections in childhood |
| Study acronym | INDIAAN |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Atopic disease, asthma |
| Intervention | BCG vaccination or placebo. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/01/1999 |
| Completion date | 01/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 120 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 01/07/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3508 AB
Netherlands
3508 AB
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
University/education
University/education
PO Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Charity
The Netherlands Organization for Scientific Research (NWO) (The Netherlands)
No information available
Netherlands Asthma Foundation (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
15/07/2021: ClinicalTrials.gov number added.
