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Completed

NCT Number: NCT00319956

Trial II of Lung Protection With Azithromycin in the Preterm Infant

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

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

Other names: zith, azith

Placebo

Drug

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.

Other names: control group

Primary outcomes

  1. Incidence of Bronchopulmonary Dysplasia (BPD)

    Time frame: diagnosis of BPD at 36wks corrected gestational age

    comparison of the % Incidence of bronchopulmonary dysplasia (BPD) for the azithromycin vs placebo groups.

Other outcomes

  1. Postnatal Steroid Use

    Time frame: Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks

    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.

  2. Number of Days on Mechanical Ventilation

    Time frame: Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks

    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.

  3. Participant Mortality

    Time frame: Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

Hubert Ballard

Other

Collaborators

  • American Lung Association

Registry information

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Apr 27, 2006
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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