Greenville, North Carolina 27834


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT01268215


Primary Contact:

Principal Investigator
Waleed M Maamoun, MD
Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

Waleed Maamoun, MD
Phone: 1-252-744-3945
Email: maamounw@ecu.edu


Backup Contact:

Email: CummingsJ@ecu.edu
James Cummings, MD
Phone: 1-252-744-4787


Location Contact:

Greenville, North Carolina 27834
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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