Trial II of Lung Protection With Azithromycin in the Preterm Infant

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bronchopulmonary Dysplasia

Intervention / Treatment
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* Drug: Azithromycin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Azithromycin Group<br>Group receives azithromycin | Drug: Azithromycin<br>* Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.<br>* Other names: zith, azith;|
| Placebo Comparator: Placebo Group<br>Group receives placebo | Drug: Placebo<br>* vehicle 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.<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Bronchopulmonary Dysplasia (BPD) | comparison of the % Incidence of bronchopulmonary dysplasia (BPD) for the azithromycin vs placebo groups. | diagnosis of BPD at 36wks corrected gestational age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature infant, respiratory distress syndrome, mechanical ventilation