Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Inf… (NCT04286464) | Clinical Trial Compass
By InvitationNot Applicable
Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Infants
Switzerland1,000 participantsStarted 2003-09
Plain-language summary
This study collects data on microbiological, genetic and environmental factors, as well as lung function parameters (e.g. spirometry, body plethysmography, lung-MRI) to assess the complex interaction of predisposing risk factors for impaired lung development and respiratory diseases.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Term Born group (H): Healthy, white and term Born infants and Children. Born 38-42 weeks postconceptional.
* Preterm group (P): Healthy, white preterm Born infants and Children. Born \<37 weeks postconceptional. Which comply with the international criteria (Jobe and Bancalari) of a diagnosis of bronchopulmonary dysplasia (BPD), or of chronic lung disease of the new-born (CLD).
* Risk pregnancy group (RP): White preterm Born infants and Children, including Twins. Born \<37 weeks postconceptional. With fetal growth restriction (FGR), intrauterine growth restriction (IUGR) or preeclampsia (PE). With gestational Diabetes (GMD). With IVF or Amnion dysfunction.
* Parents: language skills in German or French (by at least one parent).
* Both of the parents can be Smokers and may be atopics (allergy of the mother and/or the Father).
* Signed, written informed consent of the parents.
Exclusion Criteria:
* Term Born group (H): Need of respiratory support \> three days postnatal. Severe malformations or known diseases. Maternal drug abuse except smoking. Known sever maternal disease postpartum. Insufficient Knowledge of Project language (no German or French speaker). Pacemaker, continuous glucose monitor.
* Preterm group (P): Severe malformations or known diseases. Maternal drug abuse except smoking. Known severe maternal disease postpartum. Insufficient Knowledge of Project language (no German or French speaker). Pacemaker, continuous glucose monitor.
* Risk pre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Multiple Breath Washout
Timeframe: Every third year from the age of 4-6 weeks/1 year till >16 years.
2
Change in Spirometry
Timeframe: Every third year from the age of 4-6 weeks/1 year till >16 years
3
Change in Body plethysmography
Timeframe: Every third year from the age of 4-6 weeks/1 year till >16 years.
4
Change in Magnetic Resonance Imaging (MRI)
Timeframe: At the age of 4-6 weeks, 1, 3, 6, 9, 12, 15 and >16 years.
5
Change in Nasal swabs
Timeframe: At the age of 4-6 weeks, 1, 3, 6, 9, 12, 15 and >16 years.
6
Change in Weekly swabs
Timeframe: Weekly from the visit at the age of 8-12 weeks till the age of 1 year.
7
Swabs during respiratory infection
Timeframe: Any timepoint between the visit at the age of 4-6 weeks till the age of 1 year.