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Trial II of Lung Protection With Azithromycin in the Preterm Infant

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 27, 2006
Last Update Posted: June 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
American Lung Association
Information provided by (Responsible Party):
University of Kentucky

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.

Condition Intervention Phase
Bronchopulmonary Dysplasia Drug: Azithromycin Drug: D5W Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trial II of Lung Protection With Azithromycin in the Preterm Infant

Resource links provided by NLM:

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Primary outcome measure is the incidence of BPD as defined by oxygen requirement at 36 weeks gestation. [ Time Frame: Discharge or when infant reaches 36 weeks ]

Secondary Outcome Measures:
  • postnatal steroid use during NICU stay, days of IMV, and mortality. [ Time Frame: Discharge from NICU ]

Enrollment: 220
Study Start Date: September 2004
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Azith Group Drug: Azithromycin
Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.
Other Name: zith, azith
Placebo Comparator: Placebo Group Drug: D5W
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.
Other Name: sugar water

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319956

United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
American Lung Association
Principal Investigator: Hubert O Ballard, MD University of Kentucky
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Kentucky
ClinicalTrials.gov Identifier: NCT00319956     History of Changes
Other Study ID Numbers: 04-0436
First Submitted: April 27, 2006
First Posted: April 27, 2006
Last Update Posted: June 8, 2012
Last Verified: June 2012

Keywords provided by University of Kentucky:
premature infant
respiratory distress syndrome
mechanical ventilation

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases