Official Title: “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 Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Azithromycin
  • Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Azith Group
• Placebo Comparator: Placebo Group

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• postnatal steroid use during NICU stay, days of IMV, and mortality.
  • Time Frame: Discharge from NICU
    Safety Issue?: Yes

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 72 Hours

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Kentucky

Overall Clinical Trial Officials and Contacts

Hubert O Ballard, MD Principal Investigator University of Kentucky  

Overall Contact: Hubert O Ballard, MD 859-323-5530 hoball2@uky.edu

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00319956

Study ID Number: 04-0436

ClinicalTrials.gov Identifier: NCT00319956

Health Authority: United States: Food and Drug Administration