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Table 2 Inclusion criteria for patients to participate in the study

From: Prospective evaluation of hydroxychloroquine in pediatric interstitial lung diseases: Study protocol for an investigator-initiated, randomized controlled, parallel-group clinical trial

1Diagnosis of chronic (≥ 3 weeks duration) diffuse parenchymal lung disease chILD:
a) Geneticallya or
b) Histologicallyb
Diagnosis of chronic (≥ 3 weeks duration) idiopathic pulmonary hemorrhage (hemosiderosis)
2If chILD genetically diagnosed: patients of all ages (including preterm babies and adults age > 30 years)
If chILD histological diagnosed or diagnosis of idiopathic pulmonary hemorrhage: mature newborn (age ≥ 37 weeks of gestation age) to adults (age ≤ 30 years)
3Patients should be clinically stable during baseline (between visits 1 and 2) for inclusion into the studyc
4START block: no HCQ treatment in the last 12 weeks
STOP block: stable HCQ treatment for at least the last 12 weeks
5Ability of subject or/and legal representatives to understand character and individual consequences of clinical trial
6Signed and dated informed consent of the subject (if the subject has the ability) and the representatives (of under-age children) must be available before start of any specific trial procedures
  1. aSurfactant dysfunction disorders including patients with mutations in SFTPC, SFTPB, ABCA3, NKX2–1, further extremely rare entities with specific mutations; for example, in TBX4, NPC2, NPC1, NPB, COPA, LRBA and other genes
  2. bChronic pneumonitis of infancy (CPI), desquamative interstitial pneumonia (DIP), lipoid pneumonitis/cholesterol pneumonia, non-specific interstitial pneumonia (NSIP), pulmonary alveolar proteinosis after the exclusion of mutations in granulocyte-macrophage colony-stimulating factor-receptor (GMCSF-R)a/b and GMCSF autoantibodies, usual interstitial pneumonia (UIP), follicular bronchitis/bronchiolitis/lymphogenic interstitial pneumonia (LIP), storage disease with primary pulmonary involvement (e.g., Niemann-Pick)
  3. cTo determine this, attending physicians can use SpO2 in room air for patients on room air or on O2 supplement; the absolute difference in SpO2 is expected not to be ≥ 5% between visits 1 and 2. For patients on respiratory support, the summary key parameters should not change ≥ 20% between visits 1 and 2 and no major changes in other medications between visits 1 and 2