AsthmaNCT02636933
Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters
An observational study of Asthma and Allergic Rhinitis, run by Stefania La Grutta, MD at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Asthma, Allergic Rhinitis
- What is being tested?
- Lung Function Assessment
- How many people
- 152 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2015to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: A study population of 59 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=93), 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.
Who may be able to join
- Premature birth < 37 weeks
- 5 years old ≤ Age ≥ 3 years old
- Control group
- Full-term birth
- 5 years old ≤ Age ≥ 3 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Biomedicine and Molecular Immunology, IBIM
Palermo, Palermo, 90146
About this study
Official title: Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters (PRE-AR) (PREMATURELY BORN CHILDREN- ASTHMA AND ALLERGIC RHINITIS )
The PRE-AR project is a longitudinal observational study. The primary objective is the assessment of lung function parameters in late preterm preschool children.
Read the 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.
- Conditions
- Asthma, Allergic Rhinitis
- Being tested
- Lung Function Assessment
- Keywords
- Asthma, Allergic Rhinitis, Children, Atopy
- Medical subject headings
- Asthma, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Function AssessmentOther
Lung Function Assessment
| Study group | Role | What they receive |
|---|---|---|
| 59 prematurely born children | Lung function assessment of 59 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) Receives: Other: Lung Function Assessment | |
| 93 full-term born children | Lung function assessment of a Control group of full-term born children (N=93), 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. Receives: Other: Lung Function Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced oscillation technique
Longitudinal assessment of forced oscillation technique (FOT)
Measured: Baseline, 24 months, and 48 months
Spirometry
Longitudinal assessment of spirometry
Measured: Baseline, 24 months, and 48 months
Interrupter resistance
Longitudinal assessment of interrupter resistance (RINT)
Measured: Baseline, 24 months, and 48 months
Secondary outcomes (5)
Nasal nitric oxide
Longitudinal assessment of nasal nitric oxide (nNO)
Measured: Baseline, 24 months, and 48 months
Atopy
Positivity to at least one aeroallergen
Measured: Baseline
Nasal brushing
Assessment of alterations and inflammatory changes in the nasal mucosa
Measured: Baseline
Saliva sample
Phenotypic characterization through the collection of saliva samples
Measured: 24 months, and 48 months
Urine analysis
Endotypic characterization through urine proteomic analysis
Measured: Baseline, 24 months, and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2020
- Study completionFeb 2020
Why it stopped: Covid-2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefania La Grutta, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636933
- Sponsor's protocol ID
- 9/2014
- Status last verified
- Apr 2026
- First submitted
- 2 Oct 2015
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The IPD collected will be available on december 2023. 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters (PRE-AR) (PREMATURELY BORN CHILDREN- ASTHMA AND ALLERGIC RHINITIS )
- ClinicalTrials.gov ID
- NCT02636933
- Acronym / sponsor ID
- 9/2014
- Conditions
- Asthma, Allergic Rhinitis
- Keywords
- Asthma, Allergic Rhinitis, Children, Atopy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Covid-2019
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Stefania La Grutta, MDUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PRE-AR project is a longitudinal observational study. The primary objective is the assessment of lung function parameters in late preterm preschool children.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 59 prematurely born children | – | Other: Lung Function AssessmentLung function assessment of 59 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) |
| 93 full-term born children | – | Other: Lung Function AssessmentLung function assessment of a Control group of full-term born children (N=93), 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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A study population of 59 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=93), 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.
Key inclusion criteria (5 listed)
- Premature birth < 37 weeks
- 5 years old ≤ Age ≥ 3 years old
- Control group
- Full-term birth
- 5 years old ≤ Age ≥ 3 years old
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Function AssessmentLung Function Assessment | Other | 59 prematurely born children, 93 full-term born children |
Primary outcome
Forced oscillation technique
Time frame: Baseline, 24 months, and 48 months
Longitudinal assessment of forced oscillation technique (FOT)
Spirometry
Time frame: Baseline, 24 months, and 48 months
Longitudinal assessment of spirometry
Interrupter resistance
Time frame: Baseline, 24 months, and 48 months
Longitudinal assessment of interrupter resistance (RINT)
5 secondary outcomes
Nasal nitric oxide
Time frame: Baseline, 24 months, and 48 months
Atopy
Time frame: Baseline
Nasal brushing
Time frame: Baseline
Saliva sample
Time frame: 24 months, and 48 months
Urine analysis
Time frame: Baseline, 24 months, and 48 months
Results and safety
The study was stopped early (reason given: Covid-2019). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes. The IPD collected will be available on december 2023. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergic Rhinitis, run by Stefania La Grutta, MD at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid-2019). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced oscillation technique (time frame: Baseline, 24 months, and 48 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.