Brief Title
Trial II of Lung Protection With Azithromycin in the Preterm Infant
Official Title
Trial II of Lung Protection With Azithromycin in the Preterm Infant
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Incidence of Bronchopulmonary Dysplasia (BPD)
Condition
Bronchopulmonary Dysplasia
Intervention
Azithromycin
Study Arms / Comparison Groups
Azithromycin Group
Description: Group receives azithromycin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
220
Start Date
September 2004
Completion Date
June 2012
Primary Completion Date
June 2012
Eligibility Criteria
Inclusion Criteria: - birthweight less than 1250 grams admitted to UK NICU - mechanical ventilation within the first 72 hours of life Exclusion Criteria: - confirmed sepsis by blood culture - multiple congenital anomalies or known syndromes - intrauterine growth retardation with birthweight less than 10%ile for gestational age - ROM for >7 days
Gender
All
Ages
N/A - 72 Hours
Accepts Healthy Volunteers
No
Contacts
Hubert O Ballard, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00319956
Organization ID
04-0436
Responsible Party
Sponsor-Investigator
Study Sponsor
Hubert Ballard
Collaborators
American Lung Association
Study Sponsor
Hubert O Ballard, MD, Principal Investigator, University of Kentucky
Verification Date
June 2018