Trial II of Lung Protection With Azithromycin in the Preterm Infant
| Status: | Completed |
|---|---|
| Conditions: | Bronchitis |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 6/29/2018 |
| Start Date: | September 2004 |
| End Date: | June 2012 |
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.
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.
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.
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.
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
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