Clinical trial NCT00319956: Trial II of Lung Protection With Azithromycin in the Preterm Infant
Official title: Trial II of Lung Protection With Azithromycin in the Preterm Infant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchopulmonary Dysplasia
Keywords: premature infant
respiratory distress syndrome
mechanical ventilation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2006-04-27
Enrollment: 220
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of Bronchopulmonary Dysplasia (BPD)
timeFrame: diagnosis of BPD at 36wks corrected gestational age
Secondary outcomes:
Other outcomes:
measure: Postnatal Steroid Use
timeFrame: Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks
measure: Number of Days on Mechanical Ventilation
timeFrame: Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks
measure: Participant Mortality
timeFrame: Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Hubert O Ballard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ballard HO, Shook LA, Bernard P, Anstead MI, Kuhn R, Whitehead V, Grider D, Crawford TN, Hayes D Jr. Use of azithromycin for the prevention of bronchopulmonary dysplasia in preterm infants: a randomized, double-blind, placebo controlled trial. Pediatr Pulmonol. 2011 Feb;46(2):111-8. doi: 10.1002/ppul.21352. Epub 2010 Oct 20.