AZTEC-azithromycin therapy for prevention of chronic lung disease of prematurity: a statistical analysis plan for clinical outcomes

The AZTEC trial is a multi-centre, randomised, placebo-controlled trial of azithromycin to improve survival without development of chronic lung disease of prematurity (CLD) in preterm infants. The statistical analysis plan for the clinical outcomes of the AZTEC trial is described. A double-blind, ra...

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Veröffentlicht in:	Current controlled trials in cardiovascular medicine 2022-08, Vol.23 (1), p.704-11, Article 704
Hauptverfasser:	Lau, Tin Man Mandy, Lowe, John, Pickles, Timothy, Hood, Kerenza, Kotecha, Sailesh, Gillespie, David
Format:	Artikel
Sprache:	eng
Schlagworte:	Antibiotics Azithromycin Azithromycin - adverse effects Bronchopulmonary dysplasia Chronic lung disease of prematurity Clinical outcomes Dosage and administration Drug therapy Gestational Age Humans Infant, Low Birth Weight Infant, Newborn Infant, Premature Infants (Premature) Inflammation Lung diseases Lung Diseases - prevention & control Macrolide Multiple births Newborn babies Nosocomial infections Participation Premature babies Preterm infants Randomised controlled trial Statistical analysis Testing Update Ventilators
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Beschreibung
Zusammenfassung:	The AZTEC trial is a multi-centre, randomised, placebo-controlled trial of azithromycin to improve survival without development of chronic lung disease of prematurity (CLD) in preterm infants. The statistical analysis plan for the clinical outcomes of the AZTEC trial is described. A double-blind, randomised, placebo-controlled trial of a 10-day course of intravenous azithromycin (20 mg/kg for 3 days; 10 mg/kg for 7 days) administered to preterm infants born at
ISSN:	1745-6215 1745-6215
DOI:	10.1186/s13063-022-06604-2