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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00319956
Other study ID # 04-0436
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2004
Est. completion date June 2012

Study information

Verified date June 2018
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group N/A to 72 Hours
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Azithromycin
Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.
Placebo
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.

Locations

Country Name City State
United States University of Kentucky Medical Center Lexington Kentucky

Sponsors (2)

Lead Sponsor Collaborator
Hubert Ballard American Lung Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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. Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks
Other 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
Primary 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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