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

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ClinicalTrials.gov Identifier: NCT02636933
Recruitment Status : Recruiting
First Posted : December 22, 2015
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Stefania La Grutta, MD, Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy

Brief 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.

Condition or disease Intervention/treatment
Asthma Allergic Rhinitis Other: Lung Function Assessment

Detailed 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.


Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters (PRE-AR) (PREMATURELY BORN CHILDREN- ASTHMA AND ALLERGIC RHINITIS )
Study Start Date : March 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
26 prematurely born children
Lung function assessment of 26 prematurely born children (of both sex and 3-5 years old) attending as outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR)
Other: Lung Function Assessment
Lung Function Assessment

26 full-term born children
Lung function assessment of a Control group of full-term born children (N=26), recruited by a collaborative Pediatricians network within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.
Other: Lung Function Assessment
Lung Function Assessment




Primary Outcome Measures :
  1. Longitudinal assessment of lung function in late preterm children [ Time Frame: From first date of assessment until the date of first documented progression, assessed up to 100 weeks ]
    In this study forced oscillation technique (FOT), measured in hpa/l/sec will be performed in late preterm (LT) children at 3 years of age.


Secondary Outcome Measures :
  1. Longitudinal assessment of lung function in full term children [ Time Frame: From first date of assessment until the date of first documented progression, assessed up to 100 weeks ]
    In this study forced oscillation technique (FOT), measured in hpa/l/sec will be performed in full term preterm (FT) children at 3 years of age.



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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A study population of 52 prematurely born children (of both sex and 3-5 years old) attending as outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR).

A Control group of full-term born children (N=26), recruited by a collaborative Pediatricians network within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.

The subjects will be paired up according to the sex and to the age, with a ratio 1:1.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636933


Contacts
Contact: Stefania La Grutta, MD +39-091-6809682 - Fax stefania.lagrutta@ibim.cnr.it
Contact: Giovanni Viegi, MD +39-091-6809501 giovanni.viegi@ibim.cnr.it

Locations
Italy
Institute of Biomedicine and Molecular Immunology, IBIM Recruiting
Palermo, Italy, 90146
Contact: Stefania La Grutta, MD    +390916809680      
Contact: Giovanni Viegi, MD    +390916809501    giovanni.viegi@ibim.cnr.it   
Sponsors and Collaborators
Stefania La Grutta, MD

Responsible Party: Stefania La Grutta, MD, Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy., Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
ClinicalTrials.gov Identifier: NCT02636933     History of Changes
Other Study ID Numbers: 9/2014
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The IPD collected will be available on december 2020.

The following participant data will be shared:

  • Pulmonary function tests
  • Demographic characteristics

All IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.


Keywords provided by Stefania La Grutta, MD, Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy:
Asthma
Allergic Rhinitis
Children
Atopy

Additional relevant MeSH terms:
Asthma
Rhinitis
Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases