N/A
Completed N=60
The Anti-inflammatory Effect of Prophylactic Macrolides on Children With Chronic Lung Disease
Source: ClinicalTrials.gov NCT02544984 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations) — 16; 21; 3; 5 visits — p=0.473
Summary
The purpose of this study is to determine if the prophylactic use of azithromycin will reduce the total number of days when unscheduled treatment is given outside of the home in a clinic, urgent care, emergency room or hospital setting between the respiratory illness season months (October 1-March 31) and subsequent 2 month follow-up (April and May)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations) |
16; 21; 3; 5; 15; 6 | 0.473 |
| SECONDARY Number of Adverse Events |
4; 2 | 0.435 |
| SECONDARY Healthcare Cost Associated With Respiratory Illness |
— | — |
Eligibility Criteria
Inclusion Criteria
- children with a diagnosis of chronic lung disease (CLD) secondary to bronchopulmonary dysplasia (BPD) as defined by ATS.
- children who receive primary care at High Risk Infant Clinic or High Risk Children's Clinic
Exclusion Criteria
- Children with Cystic Fibrosis or bronchiectasis
- Children with cardiac arrhythmias
- Children with cyanotic heart disease
- Children with colitis
- Children with a known Macrolide allergy
- Children taking medications known to interact with macrolides
- Children with short bowel syndrome
- Children with kidney or liver failure
Data sourced from ClinicalTrials.gov (NCT02544984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.