Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters

Asthma Clinical Trial

Official title:

Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters (PRE-AR) (PREMATURELY BORN CHILDREN- ASTHMA AND ALLERGIC RHINITIS )

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02636933
• Other study ID #: 9/2014
• Status: Active, not recruiting
• Start date: March 2015
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The PRE-AR project is a longitudinal observational study. The primary objective is the assessment of lung function parameters in late preterm preschool children.

Description:

The PRE-AR project is a longitudinal observational study. The primary objective is the assessment of lung function parameters in late preterm preschool children.

Pulmonary function tests will be performed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 152
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

Case group

Inclusion Criteria:

• Premature birth < 37 weeks

• 5 years old = Age = 3 years old

Control group

Inclusion Criteria:

• Full-term birth

• 5 years old = Age = 3 years old

Exclusion Criteria of both groups:

• Pulmonary bronchodysplasia (BDP)

• Acute respiratory infection

• Immunological and metabolic system disease

• Malformation of upper respiratory tract

• Topical or systemic therapies, with antibiotics, antihistaminics and corticosteroids, in the previous 30 days

• Patients with neurological pathologies

• Patients that are not able to perform the lung function tests

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• Lung Function Assessment
Lung Function Assessment

Locations

Country	Name	City	State
Italy	Institute of Biomedicine and Molecular Immunology, IBIM	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Stefania La Grutta, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced oscillation technique	Longitudinal assessment of forced oscillation technique (FOT)	Baseline, 24 months, and 48 months
Primary	Spirometry	Longitudinal assessment of spirometry	Baseline, 24 months, and 48 months
Primary	Interrupter resistance	Longitudinal assessment of interrupter resistance (RINT)	Baseline, 24 months, and 48 months
Secondary	Nasal nitric oxide	Longitudinal assessment of nasal nitric oxide (nNO)	Baseline, 24 months, and 48 months
Secondary	Atopy	Positivity to at least one aeroallergen	Baseline
Secondary	Nasal brushing	Assessment of alterations and inflammatory changes in the nasal mucosa	Baseline
Secondary	Saliva sample	Phenotypic characterization through the collection of saliva samples	24 months, and 48 months
Secondary	Urine analysis	Endotypic characterization through urine proteomic analysis	Baseline, 24 months, and 48 months