Trial II of Lung Protection With Azithromycin in the Preterm Infant

Condition(s) targeted: Bronchopulmonary Dysplasia

Intervention: Azithromycin (Drug); D5W (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Kentucky

Official(s) and/or principal investigator(s):
Hubert O Ballard, MD, Principal Investigator, Affiliation: University of Kentucky

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

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.

Official title: Trial II of Lung Protection With Azithromycin in the Preterm Infant

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

Primary outcome: Primary outcome measure is the incidence of BPD as defined by oxygen requirement at 36 weeks gestation.

Secondary outcome: postnatal steroid use during NICU stay, days of IMV, and mortality.

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.

Minimum age: N/A. Maximum age: 72 Hours. Gender(s): Both.

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

Hubert O Ballard, MD, Phone: 859-323-5530, Email: hoball2@uky.edu

University of Kentucky Medical Center, Lexington, Kentucky 40536, United States; Recruiting
Hubert O Ballard, MD, Principal Investigator
Lori A Shook, MD, Sub-Investigator

Starting date: September 2004
Ending date: December 2009
Last updated: February 14, 2008