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| Name | Class |
|---|---|
| American Lung Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin Group | Active Comparator | Group receives azithromycin |
|
| Placebo Group | Placebo Comparator | Group receives placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days. |
|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Postnatal Steroid Use | Steroids will be provided as needed based on Standard of Care. Data are presented as the percent of participants that received steroids between birth and discharge from the NICU. | Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks |
| Number of Days on Mechanical Ventilation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hubert O Ballard, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20963840 | Derived | 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. |
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The study recruitment started 9/04 ended 8/08. All subjects were enrolled after admission to NICU. Randomized treatment started within 12 hrs of beginning ventilatory support. If outborn, consent was obtained from parent(s) after phone discussion by the research staff. The consents were faxed, witnessed and brought back by the Transport Team.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azith Group | Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days. |
| FG001 | Placebo Group | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azith Group | Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days. |
| BG001 | Placebo Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Bronchopulmonary Dysplasia (BPD) | comparison of the % Incidence of bronchopulmonary dysplasia (BPD) for the azithromycin vs placebo groups. | Mortality was 18% in the Azithromycin group and 22% in the Placebo group, thus 91 participants in the Azithromycin group and 85 participants in the Placebo group were analyzed. | Posted | Number | percentage w/ BPD | diagnosis of BPD at 36wks corrected gestational age |
|
1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azith Group | Azithromycin : Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days. |
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The number of participants for this study was quite small. A large scale trial is required to draw any conclusions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hubert O. Ballard | University of Kentucky Medical Center | 859-323-1496 | hoball2@uky.edu |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Placebo | Drug | 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. |
|
|
Participants will be placed on mechanical ventilation as necessary based on standard of care. Data are presented as the percent of participants in each group receiving mechanical ventilation. |
| Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks |
| Participant Mortality | Data will be collected on the number of participants that did not survive to discharge from the NICU. Data are presented as the percent of participants that did not survive. | Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | gestational age, weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Other Pre-specified | Postnatal Steroid Use | Steroids will be provided as needed based on Standard of Care. Data are presented as the percent of participants that received steroids between birth and discharge from the NICU. | Posted | Number | percentage of participants | Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks |
|
|
|
| Other Pre-specified | Number of Days on Mechanical Ventilation | Participants will be placed on mechanical ventilation as necessary based on standard of care. Data are presented as the percent of participants in each group receiving mechanical ventilation. | Posted | Mean | Standard Deviation | days | Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks |
|
|
|
| Other Pre-specified | Participant Mortality | Data will be collected on the number of participants that did not survive to discharge from the NICU. Data are presented as the percent of participants that did not survive. | Posted | Number | percentage of mortality | Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks |
|
|
|
| 20 |
| 111 |
| 0 |
| 111 |
| 0 |
| 111 |
| EG001 | Placebo Group | 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. | 24 | 109 | 0 | 109 | 0 | 109 |
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| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D012120 | Respiration Disorders |
| Organic Chemicals |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |