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Observational study

 

Definitions:

Prevalent cases are cases of chILD already diagnosed and can be registered here.

Incident cases are newly occurring cases of chILD and will be included in the observational study after registration.

 

 

What will be observed?

We will observe children with a diagnosis of Interstitial Lung Disease over the first year of their initial diagnosis (i.e. these are incident or newly occurring cases). We will collect standard clinical measures at routine review periods. The study will also look at the social and health economic impacts of the disease.

 

Aim of study

To better understand the course and burden of the disease and how different practices may influence outcomes.

 

 

Study Flow Chart

The database study has observations made at study entry to the study (minimum dataset).

 

  • ‘I have a chILD’ notification: Minimal data (symptoms, signs, hypoxaemia, radiological abnormality, duration, child initials, site details, email address)
  • Referral information for Peer Review (see Peer Review information page): Complete dataset. Quality of Life questionnaire + utilisation of health care

 

Incident cases will be further observed at 1, 2, 3, 6 and 12 months

  1. 4 (+/-1) week post I have a chILD: Minimal data (Outcome, HR, RR, SpO2, Treatment) + Spirometry if able
  2. 8 (+/-1) week post I have a chILD: Minimal data (Outcome, HR, RR, SpO2, Treatment) + Spirometry if able
  3. 12 (+/-1) week post I have a chILD: Minimal data (Outcome, HR, RR, SpO2, Treatment) + Spirometry if able + utilisation of health care
  4. 6 (+/-1) months post I have a chILD: Minimal data (Outcome, HR, RR, SpO2, Treatment) +  CXR + Spirometry if able + utilisation of health care
  5. 12 (+/-2) months post I have a chILD: Review of case and diagnosis. To include Minimal data (Outcome, HR, RR, SpO2, Treatment) + QoL + CXR + Spirometry if able + utilisation of health care

After 1 year these cases will also be observed annually like the prevalent cases.

 

Prevalent cases will be further observed at 6 and 12 months, and then annually.

  1. 6 (+/-1) months post I have a chILD: Minimal data (Outcome, HR, RR, SpO2, Treatment) +  CXR + Spirometry if able + utilisation of health care
  2. 12 (+/-2) months post 'I have a chILD': Review of case and diagnosis. To include Minimal data (Outcome, HR, RR, SpO2, Treatment)  +QOL + CXR + Spirometry if able.
  3. Annual review of case and diagnosis. To include Minimal data (Outcome, HR, RR, SpO2, Treatment) + QoL + CXR + Spirometry if able + utilisation of health care

Inclusion criteria

Inclusion to the Observational study are those children who are eligible for the chILD-EU Database and Biobank

This includes infants and children presenting to hospital with at least three of the following four criteria are present:

  1. respiratory symptoms for at least 14 days (cough, rapid and/or difficult breathing, or exercise intolerance),
  2. respiratory signs (tachypnea, adventitious sounds, retractions, digital clubbing, failure to thrive, or respiratory failure),
  3. hypoxemia, and
  4. diffuse abnormalities on a chest radiograph or computed tomography (CT) scan. Or, a child with Clinician suspected interstitial lung disease.

Start/End of study

The study will start at the point of referral of the case to the chILD-EU team when consent has been obtained. The study will end 12 months later.

 

Patient information / Informed Consent

Parent informed consent must be obtained for inclusion in these studies. Patient information sheets and consent forms will be emailed to clinicians who identify to chILD-EU a potential case.

Patient information sheets and consent forms are also available here (English, German, Turkish, Italian)

 

Interested parent / clinicians contact please

Parents

You may wish to download and read the information sheets and consent forms. Please use these for discussion with your local respiratory paediatrician and inform them that you wish to be included in the study. Your local respiratory paediatrician will be able to link with the chILD-EU team to enable this.

 

Clinicians

If you have or suspect a case of chILD, please identify these details via the website here.

We will then email appropriate supporting documentation and establish a contact with the research team.