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Trial II of Lung Protection With Azithromycin in the Preterm Infant

This study has been completed.
Sponsor:
Collaborator:
American Lung Association
Information provided by (Responsible Party):
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00319956
First received: April 27, 2006
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Bronchopulmonary Dysplasia
 Drug: Azithromycin
Drug: D5W
 Phase 2

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
Official Title: Trial II of Lung Protection With Azithromycin in the Preterm Infant

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 220
Study Start Date: September 2004
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Azith Group 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
Placebo Comparator: Placebo Group 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

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.

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319956

Locations
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
American Lung Association
Investigators
Principal Investigator: Hubert O Ballard, MD University of Kentucky
  More Information

No publications provided

Responsible Party: University of Kentucky
ClinicalTrials.gov Identifier: NCT00319956     History of Changes
Other Study ID Numbers: 04-0436
Study First Received: April 27, 2006
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Kentucky:
premature infant
respiratory distress syndrome
mechanical ventilation

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
 Infant, Newborn, Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013