Trial II of Lung Protection With Azithromycin in the Preterm Infant

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00319956
• Date of registration: 27/04/2006
• Primary sponsor: University of Kentucky
• Public title: Trial II of Lung Protection With Azithromycin in the Preterm Infant
• Scientific title: Trial II of Lung Protection With Azithromycin in the Preterm Infant
• Date of first enrolment: September 2004
• Target sample size: 220
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00319956
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Hubert O Ballard, MD
• Affiliation: University of Kentucky

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 72 Hours
Gender: Both

Health Condition(s) or Problem(s) studied

Bronchopulmonary Dysplasia

Intervention(s)

Drug: Azithromycin

Drug: D5W

Primary Outcome(s)

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(s)

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

Secondary ID(s)

04-0436

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

American Lung Association