NCT04286464Enrolling by invitation
Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Infants
Source: ClinicalTrials.gov · Last updated 29 Sept 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 9 Oct 2019
- Start date
- Sept 2003
- Primary completion date
- Sept 2050
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- NCT number
- NCT04286464
What you commit to
- Study type: Observational
- Planned participants: 1000
- From Sept 2003 to the primary completion date, Sept 2050
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Risk pregnancy group (RP): Insufficient Knowledge of Project language (no German or French speaker). Concurrent participation in another study. Participants, which lead to heterogeneity in genetic analysis and thus preclude any findings.
Lab values
- 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.
Who the study is looking for
- 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.
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Children's Hospital Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.