Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.
| Status: | Completed |
|---|---|
| Conditions: | Bronchitis |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2010 |
| End Date: | December 2013 |
| Contact: | Waleed Maamoun, MD |
| Email: | maamounw@ecu.edu |
| Phone: | 1-252-744-3945 |
The Effect of Endotracheal Instillation of Surfactant With and Without Budesonide on the Development of Bronchopulmonary Dysplasia in Ventilator-dependent, Extremely Low Birth Weight Infants: A Pilot Study
A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of
pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic
treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low
birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the
tracheal aspirate before and after instillation of the study drugs.
pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic
treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low
birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the
tracheal aspirate before and after instillation of the study drugs.
Bronchopulmonary Dysplasia (BPD) is still one of the most common complications of ventilated
premature infants. Lung inflammation plays a major role in its pathogenesis. Systemic
steroids can be given to control this inflammatory process but their widespread use is
limited by their systemic side effects and concerns for long neurodevelopmental adverse
sequelae. Delivering steroids by inhalation which has been proven to be effective in young
infants with asthma has been shown to be unsatisfactory for ELBW infants with BPD. This may
be due to the fact that current delivery devices do not meet the requirements of the
specific anatomical and physiologic characteristics of the airways and breathing patterns in
this special group of patients. A novel approach to facilitate delivery directly to the
lungs, thereby avoiding systemic concerns has been demonstrated in a recent study in which
budesonide ( a topical steroid) was given to ventilated preterm infants using surfactant as
a vehicle.
premature infants. Lung inflammation plays a major role in its pathogenesis. Systemic
steroids can be given to control this inflammatory process but their widespread use is
limited by their systemic side effects and concerns for long neurodevelopmental adverse
sequelae. Delivering steroids by inhalation which has been proven to be effective in young
infants with asthma has been shown to be unsatisfactory for ELBW infants with BPD. This may
be due to the fact that current delivery devices do not meet the requirements of the
specific anatomical and physiologic characteristics of the airways and breathing patterns in
this special group of patients. A novel approach to facilitate delivery directly to the
lungs, thereby avoiding systemic concerns has been demonstrated in a recent study in which
budesonide ( a topical steroid) was given to ventilated preterm infants using surfactant as
a vehicle.
Inclusion Criteria:
1. Birth weight 501-1000 g and ≤ 28 weeks gestational age
2. Diagnosed as RDS requiring mechanical ventilation and surfactant therapy during the
first 4 hours after birth
3. Still ventilated on day 5-9 of life.
4. An interval of at least 24 hours' duration between the last dose of indomethacin and
the endotracheal instillation of study drug.
Exclusion Criteria:
1. Congenital or chromosomal anomalies
2. Occurrence of perinatal sepsis
3. Use of intravenous steroids > 7 days
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