Defining respiratory exacerbations in children and adolescents with bronchiectasis for clinical research
| Statement 1: Definition of exacerbation as an outcome for clinical trials |
| 1a: Non-severe exacerbation |
| In children and adolescents with bronchiectasis, we suggest that a non-severe respiratory exacerbation is considered present when there is a change in respiratory management (prescribed antibiotics for respiratory symptoms and/or intensification of airway clearance) DUE TO at least ONE of the following: |
| • An increase in sputum volume/purulence OR change in cough character (dry to wet) OR increased wet/productive cough frequency for ≥3 days |
| • Onset of chest pain or discomfort |
| • Onset of new or worsening chest auscultation or palpable (vibration) secretion findings |
| • Onset of new or worsening radiographic changes (e.g. chest radiography) |
| • Drop in FEV1 (>10%) |
| NOTE: 1) blood markers reflective of a pulmonary exacerbation (e.g. elevated CRP, neutrophils, serum amyloid A, IL-6) may also be present; 2) systemic symptoms (fever, fatigue, malaise, change in child's behaviour or appetite) may also herald onset of an exacerbation, but are non-specific |
| 1b: Severe exacerbation |
| In children and adolescents with bronchiectasis, we suggest that a severe respiratory exacerbation is considered present when the criteria for an exacerbation (see Statement 1a) are met AND a clinician deems hospitalisation for intravenous antibiotics and/or supportive management is indicated BECAUSE of at least ONE of the following: |
| • Onset of new or worsening tachypnoea (age-adjusted respiratory rate (breaths·min−1) >50 if aged <12 months; >40 if aged 1–2 years; >30 if aged 3–9 years; >25 if aged 10–18 years) |
| • Onset of new or worsening dyspnoea (increased work of breathing) |
| • Onset of new or worsening hypoxia (SpO2 persistently <92% in room air or 4% below stable state) |
| • Any haemoptysis |
| • Worsening chest pain |
| Statement 2: Definition of a non-severe exacerbation that warrants treatment for clinical trials |
| In children and adolescents with bronchiectasis, we suggest that a non-severe respiratory exacerbation is considered present when at least ONE of the following develops: |
| • An increase in sputum volume/purulence OR change in cough character (dry to wet) OR increased wet/productive cough frequency for ≥3 days OR |
| • Onset of chest pain or discomfort OR |
| • Onset of new or worsening chest auscultation or palpable (vibration) secretion findings OR |
| • Onset of new or worsening radiographic changes (e.g. chest radiography) OR |
| • Drop in FEV1 (>10%) |
| NOTE: 1) blood markers reflective of a pulmonary exacerbation (e.g. elevated CRP, neutrophils, serum amyloid A, IL-6) may also be present; 2) systemic symptoms (fever, fatigue, malaise, change in child's behaviour or appetite) may also herald onset of an exacerbation, but are non-specific |
| Statement 3: Definition of resolution of a non-severe exacerbation |
| In children and adolescents with bronchiectasis, we suggest that a non-severe respiratory exacerbation is considered resolved when the child's or adolescent's clinical state has returned to baseline state (respiratory symptoms and signs) for at least 2 consecutive days |
FEV1: forced expiratory volume in 1 s; CRP: C-reactive protein; IL: interleukin; SpO2: peripheral oxygen saturation.