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Trial II of Lung Protection With Azithromycin in the Preterm Infant

H

Hubert Ballard

Status and phase

Completed
Phase 2

Conditions

Bronchopulmonary Dysplasia

Treatments

Drug: Placebo
Drug: Azithromycin

Study type

Interventional

Funder types

Other

Identifiers

NCT00319956
04-0436

Details and patient eligibility

About

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.

Full 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.

Enrollment

220 patients

Sex

All

Ages

Under 72 hours old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

220 participants in 2 patient groups, including a placebo group

Azithromycin Group
Active Comparator group
Description:
Group receives azithromycin
Treatment:
Drug: Azithromycin
Placebo Group
Placebo Comparator group
Description:
Group receives placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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