Trial II of Lung Protection With Azithromycin in the Preterm Infant

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Bronchopulmonary dysplasia
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Brief Title

Trial II of Lung Protection With Azithromycin in the Preterm Infant

Official Title

Trial II of Lung Protection With Azithromycin in the Preterm Infant

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Incidence of Bronchopulmonary Dysplasia (BPD)

Condition

Bronchopulmonary Dysplasia

Intervention

Azithromycin

Study Arms / Comparison Groups

 Azithromycin Group
Description:  Group receives azithromycin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

220

Start Date

September 2004

Completion Date

June 2012

Primary Completion Date

June 2012

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

Gender

All

Ages

N/A - 72 Hours

Accepts Healthy Volunteers

No

Contacts

Hubert O Ballard, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00319956

Organization ID

04-0436

Responsible Party

Sponsor-Investigator

Study Sponsor

Hubert Ballard

Collaborators

 American Lung Association

Study Sponsor

Hubert O Ballard, MD, Principal Investigator, University of Kentucky

Verification Date

June 2018