Trial II of Lung Protection With Azithromycin in the Preterm Infant

Phase 2

Completed

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Drug: Placebo; Drug: Azithromycin

• Registration Number: NCT00319956
• Lead Sponsor: Hubert Ballard

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 Timeline

• Study Start: 2004-09
• Study First Submitted: 2006-04-27
• Study First Submitted QC: 2006-04-27
• Study First Posted: 2006-04-27
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2013-07-29
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-25
• Last Update Submitted: 2018-06-25
• Results First Posted: 2018-06-27
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Group receives placebo
Azithromycin Group	Azithromycin	Group receives azithromycin

Primary Outcome Measures

Name	Time	Method
Incidence of Bronchopulmonary Dysplasia (BPD)	diagnosis of BPD at 36wks corrected gestational age	comparison of the % Incidence of bronchopulmonary dysplasia (BPD) for the azithromycin vs placebo groups.

Trial Locations

Locations (1)

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States