Trial II of Lung Protection With Azithromycin in the Preterm Infant - Tabular View

Tracking Information

First Received Date ^ICMJE

April 27, 2006

Last Updated Date

March 27, 2009

Start Date ^ICMJE

September 2004

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Primary outcome measure is the incidence of BPD as defined by oxygen requirement at 36 weeks gestation.

Change History

Complete list of historical versions of study NCT00319956 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

postnatal steroid use during NICU stay, days of IMV, and mortality.

Descriptive Information

Brief Title ^ICMJE

Trial II of Lung Protection With Azithromycin in the Preterm Infant

Official Title ^ICMJE

Trial II of Lung Protection With Azithromycin in the Preterm Infant

Brief 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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Prevention

Condition ^ICMJE

Bronchopulmonary Dysplasia

Intervention ^ICMJE

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
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

Study Arms / Comparison Groups

Azith Group: Active Comparator
Intervention: Drug: Azithromycin
Placebo Group: Placebo Comparator
Intervention: Drug: D5W

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

220

Estimated Completion Date

March 2011

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 72 Hours

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00319956

Responsible Party

Hubert O. Ballard, MD, University of Kentucky

Study ID Numbers ^ICMJE

04-0436

Study Sponsor ^ICMJE

University of Kentucky

Collaborators ^ICMJE

American Lung Association

Investigators ^ICMJE

Principal Investigator:

Hubert O Ballard, MD

University of Kentucky

Information Provided By

University of Kentucky

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP