Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Infants

NCT04286464 | Enrolling By Invitation

• 1 other identifier: BILD
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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 of predisposing risk factors for impaired lung development and respiratory diseases.

Conditions

Healthy Volunteers

Keywords

infants; children; healthy; term born; preterm born; fetal growth restriction; intrauterine growth restriction or preeclampsia; with gestational diabetes; with IVF or amnion dysfunction

Outcome Measures

Primary Outcomes (7)

• Change in Multiple Breath Washout

  Longitudinal assessment of lung volume and ventilation inhomogeneity

  Every third year from the age of 4-6 weeks/1 year till >16 years.

• Change in Spirometry

  Longitudinal assessment of long volumes

  Every third year from the age of 4-6 weeks/1 year till >16 years

• Change in Body plethysmography

  Longitudinal assessment of ventilation inhomogeneity.

  Every third year from the age of 4-6 weeks/1 year till >16 years.

• Change in Magnetic Resonance Imaging (MRI)

  Longitudinal assessment of regional lung perfusion and ventilation

  At the age of 4-6 weeks, 1, 3, 6, 9, 12, 15 and >16 years.

• Change in Nasal swabs

  Longitudinal assessment of viral and bacterial colonization of the nasal swab

  At the age of 4-6 weeks, 1, 3, 6, 9, 12, 15 and >16 years.

• Change in Weekly swabs

  Respiratory virus and bacterial diagnostic

  Weekly from the visit at the age of 8-12 weeks till the age of 1 year.

• Swabs during respiratory infection

  Respiratory viruses and Bacteria, changes of the microbial flora

  Any timepoint between the visit at the age of 4-6 weeks till the age of 1 year.

Secondary Outcomes (10)

• Respiratory Rate (RR)

  From the visit at the age of 4-6 weeks till the age of 1 year.

• Urine

  At the age of 4-6 weeks.

• Cord blood

  At birth.

• Capillary blood markers

  At the age of 1, 3, 6, 9, 12, 15 and >16 years.

• Skin Prick Test

  At the age of 3, 6, 9, 12, 15 and >16 years.

Study Arms (3)

Term born group (H)

Healthy, white and term Born infants and Children Born 38-42 weeks postconceptional

Other: No intervention

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)

Other: No intervention

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 (GDM) With IVF or Amnion dysfunction

Other: No intervention

Interventions

No intervention OTHER

No intervention

Preterm group (P); Risk pregnancy group (RP); Term born group (H)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healty term born, healthy preterm born infants and children and white preterm born infants and children from risk pregnancies.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Children's Hospital

Bern, 3010, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal swabs, oropharyngeal swabs, nasal brush, sputum, cord blood, blood, urine

MeSH Terms

Conditions

Fetal Growth Retardation; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced

Study Officials

• Philipp Latzin, MD PhD

  University Children's Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: February 27, 2020
• Study Start: September 1, 2003
• Primary Completion (Estimated): September 1, 2050
• Study Completion (Estimated): January 1, 2051
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

CH (1)