Trial II of Lung Protection With Azithromycin in the Preterm Infant
The hypothesis of this study is that administration of azithromycin to ventilated premature infants will decrease the incidence and severity of BPD.
The purpose of this study is to determine if Azithromycin treatment is beneficial for prevention of bronchopulmonary dysplasia in preterm infants.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Trial II of Lung Protection With Azithromycin in the Preterm Infant|
- Primary outcome measure is the incidence of BPD as defined by oxygen requirement at 36 weeks gestation. [ Time Frame: Discharge or when infant reaches 36 weeks ] [ Designated as safety issue: No ]
- postnatal steroid use during NICU stay, days of IMV, and mortality. [ Time Frame: Discharge from NICU ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2004|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Azith Group||
Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.
Other Name: zith, azith
|Placebo Comparator: Placebo Group||
Dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
Other Name: sugar water
The survival of preterm infants has increased dramatically and has been associated with an increase in BPD. The incidence of BPD among extremely low birthweight infants ranges from 45% to 90%. Development of BPD is associated with both antenatal (maternal chorioamnionitis often due to Ureaplasma is related to BPD) and postnatal complications (oxygen toxicity, barotrauma, late onset infections). These insults appear to lead to an inflammatory response with resultant arrest of normal alveolar and vascular development. Multiple human studies support the role of inflammation in the development of BPD.
Evaluating a medication that could decrease the inflammation in BPD, with minimal side effects, could significantly improve the morbidities of prematurity and the financial burden incurred by parents. Macrolide antibiotics (erythromycin and azithromycin) have been shown to have anti-inflammatory properties that are independent of their antimicrobial properties.
Azithromycin has the potential to decrease the severity of ventilator-induced pulmonary inflammation that is commonly seen in BPD.
|United States, Kentucky|
|University of Kentucky Medical Center|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Hubert O Ballard, MD||University of Kentucky|