Trial II of Lung Protection With Azithromycin in the Preterm Infant

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Trial II of Lung Protection With Azithromycin in the Preterm Infant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319956
• Other study ID #: 04-0436
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

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