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| Sponsor: | University of Kentucky |
|---|---|
| Collaborator: |
American Lung Association |
| Information provided by: | University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT00319956 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchopulmonary Dysplasia |
Drug: Azithromycin Drug: D5W |
Phase II |
| Study Type: | Interventional |
| 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 |
| Estimated Enrollment: | 220 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Azith Group |
Drug: Azithromycin
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 |
Drug: D5W
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.
Eligibility| Ages Eligible for Study: | up to 72 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Kentucky | |
| University of Kentucky Medical Center | |
| Lexington, Kentucky, United States, 40536 | |
| Principal Investigator: | Hubert O Ballard, MD | University of Kentucky |
More Information
| Responsible Party: | Hubert O. Ballard, MD, University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT00319956 History of Changes |
| Other Study ID Numbers: | 04-0436 |
| Study First Received: | April 27, 2006 |
| Last Updated: | October 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
premature infant respiratory distress syndrome mechanical ventilation |
|
Bronchopulmonary Dysplasia Ventilator-Induced Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases |
Infant, Newborn, Diseases Azithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
