Register information
The European chILD-EU register has developed standardized protocols for diagnosis and therapy. These will continuously be improved. Moreover, the register will promote scientific-clinical research. Patients included into the register are offered a peer review by international experts for confirmation of the initial diagnosis.
The primary goal of the European chILD-EU register and biobank are the long-term recording and conservation of data and biomaterials from as many cases with rare children’s interstitial lung diseases (chILD).
Physicians interested in including patients in the register should fill in the registration form.
Cooperation and input into these activities are very welcomed!
The study is registered at clin.gov (NCT02852928).
Long term observation
All cases of suspected or proven children's interstitial lung disease, in particular also unclear cases will be included for diagnosis and observation.
Current focus:
- Persistent tachypnea of infancy (“NEHI”)
- All familial cases
- All children with a lung biopsy
- All other cases YOU are interested in
- We are interested in prevalent cases, i.e. those where chILD is already diagnosed, and in incident cases, i.e. newly occurring cases of chILD.
What will be observed?
- initial diagnosis process including molecular diagnosis
- long term follow up: baseline, 6 month, then annually
- standard clinical measures, social and health economic outcomes
Aim of study
Patient information / Informed Consent
Interested clinicians, patients, parents and families
A benefit for your participation is that after providing all information and materials needed you will receive an expert advice concerning treatment and a diagnosis by an expert board including pneumologists, pathologists and radiologists and if applicable and desired also an genetic analysis to exclude a genetic background as source for your disease. For participation please 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.
If you have or suspect a patient with children interstitial lung disease or rare lung disease, please contact us.
We will then email appropriate supporting documentation and establish a contact with the research team.
For the collection of biomaterials in a central biobank as an integral part of the register was implemented. The contributing physician can follow biomaterials at any time. We have internationally harmonized biomaterial handling and storage procedures developed and put into action.
Interstitial lung diseases in infants and children are a huge burden for the children and their families. Due to the mostly chronic character and high morbidity, for example, the health-related quality of life is reduced in these children and the costs of care are estimated to be high due to medication, inpatient and outpatient treatment and a high amount of care.
The aim of chiLDEU.net is to gather information on quality of life as well as on utilisation of health care as little is known on these aspects.
- Health-related quality of life
- Cost-of-illness
We will analyse healthcare utilisation in ILD children using questionnaires and calculate resulting costs of care. Findings on utilisation will be compared for different European countries. Furthermore indirect costs resulting out of possible work absenteeism of parents caring for ILD children will be estimated.
Insights in costs of ILD point out the impact of these diseases on health care systems and society. Furthermore, they provide a basis for understanding the allocation of health care resources and therefore can optimise healthcare. Regarding rare childhood interstitial lung diseases a cost-of-illness study could help to raise awareness of these rare diseases. The results can also be used in economic evaluation studies, e.g. modelling of the cost-effectiveness of interventions into child.
Ethics
According to the Guideline for Good Clinical Practice (GCP) an ethics approval will be obtained for the Register/Biobank, the observational study and the interventional studies prior their respective start.
The lead ethics committee of these studies, the ethics committee of the medical faculty of the University of Munich has approved the register and biobank observational study. The ethics vote can be found here.
Many other countries and sites have also approved the chILD-EU register and biobank. If you need help and documents to obtain a local ethics approval, please contact us.
Single or few subjects whose data, imaging and biomaterials are submitted for review from the external sites can be included into the register, using the appropriate pseudonymisation and written informed consent from parents and/or child if old enough.
Data Safety
In the child-EU network all medical data are stored pseudonymized. Identifying patient data (IDAT) are stored completely separately from medical data (MDAT). IDAT and MDAT are strictly separated in two different databases at separate locations and with separate administration.
IDAT are collected in the central patient list which is hosted at the University of Marburg. The so-called Mainzelliste, an open-source pseudonymization software (www.mainzelliste.de), assigns non-speaking pseudonyms to patient data, i.e. the entered personal data cannot be reconstructed from the pseudonym. The application is designed such that identifying data is entered to the IDAT server directly from the users’ web browser without being transmitted over the MDAT server.
MDAT, the medical data are stored in a database at the Ludwig-Maximilians University of Munich (LMU).
The whole network traffic between the internet and the firewall systems, between the firewall systems and the application servers and between the application and the Red-Cap database servers is controlled by network based intrusion detection systems. All warnings and errors are logged in a separated database and permanently controlled by internal implemented analysis tools.
All medical database servers and all log files of the firewall systems are backuped daily.
The Red-Cap program is an open source program permanently updated to meet all requirements according to GCP, EMEA and FDA (21 CFR Part 11).
For reason of data protection and security patients and authorized persons are assigned to different research centers (hospitals, medical practices, research groups). Authorized persons only have access to the pseudonymized medical data of patients assigned to the same center.
In case of consultant services and requests the consultant at LMU Munich can get access to special medical data of a patient from another center, only if the parents/guardians consented to this.
Only monitors and the principal investigator and his coworkers of the chILD-EU network can get the right to view all medical data of all centers. Roles and rights of each authorized person with access to the medical database are logged in detail in audit trail files and backed-up daily together with the medical data for permanent control.