Clinical trial NCT01268215: Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary Dysplasia
Budesonide
Infasurf
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2010-12-29
Enrollment: 45
Sex: ALL
Minimum age (years): 24
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: To measure the effect of surfactant with and without Budesonide on the development of BPD in ELBW infants.
timeFrame: Supplemental oxygen requirement at 36 weeks' postmenstrual age (PMA)
Secondary outcomes:
measure: To measure the effect of surfactant with and without Budesonide on the inflammatory cytokines in tracheal aspirates.
timeFrame: The measurement of cytokines in tracheal aspirate samples will be done at the end of the study.
Other outcomes:
Locations:
city: Greenville
country: United States
facility: NICU-Pitt County Memorial Hospital
state: North Carolina
Study officials:
affiliation: Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University
name: Waleed M Maamoun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University
name: James Cummings, MD
role: STUDY_DIRECTOR
affiliation: Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University
name: Scott MacGilvray, MD
role: STUDY_CHAIR
affiliation: Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University
name: Karl Kaminski, RRT-NPS
role: STUDY_CHAIR
References: