Status:
ENROLLING_BY_INVITATION
Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Infants
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Healthy Volunteers
Eligibility:
All Genders
Brief 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 ...
Detailed Description
Background: Lung development and growth is a complexly orchestrated process starting prenatally in the first embryonic weeks, and ending, with the last important stages of alveolarization from the 24...
Eligibility Criteria
Inclusion
- 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
- 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 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2051
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04286464
Start Date
September 1 2003
End Date
January 1 2051
Last Update
September 29 2021
Active Locations (1)
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1
University Children's Hospital
Bern, Switzerland, 3010