Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (two study drugs group) | Experimental | The standard management + two study drugs (endotracheal instillation of a mixture containing budesonide and Infasurf) |
|
| B (one study drug group) | Active Comparator | The standard management + one study drug (endotracheal instillation of Infasurf only). |
|
| C (no study drug group) | Sham Comparator | The standard management only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infasurf | Drug | Endotracheal instillation of Infasurf once per week for three weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To measure the effect of surfactant with and without Budesonide on the development of BPD in ELBW infants. | The main goal of the study is to determine whether endotracheal instillation of surfactant (Infasurf) with or without potent topical steroid (Budesonide) reduces the development of Bronchopulmonary Dysplasia (BPD) in Extremely Low Birth Weight (ELBW) infants at high risk of BPD. | Supplemental oxygen requirement at 36 weeks' postmenstrual age (PMA) |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the effect of surfactant with and without Budesonide on the inflammatory cytokines in tracheal aspirates. | Tracheal aspirate samples will be collected before instillation of each dose of the study drug, 7 days after the last dose if the infant is still intubated, and prior to elective extubation regardless of when extubation occurs. Tracheal aspirate samples will be obtained from the control (standard management) group in the same way and using the same time frame as the treatment groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Waleed Maamoun, MD | Contact | 1-252-744-3945 | maamounw@ecu.edu | |
| James Cummings, MD | Contact | 1-252-744-4787 | CummingsJ@ecu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Waleed M Maamoun, MD | Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University | Principal Investigator |
| James Cummings, MD | Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NICU-Pitt County Memorial Hospital | Recruiting | Greenville | North Carolina | 27834 | United States |
Not provided
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C117342 | calfactant |
| D019819 | Budesonide |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pulmicort | Drug | Endotracheal instillation, once per week for three weeks |
|
|
| Sham | Other | None instilled through the endotracheal tube |
|
|
| The measurement of cytokines in tracheal aspirate samples will be done at the end of the study. |
| Scott MacGilvray, MD | Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University | Study Chair |
| Karl Kaminski, RRT-NPS | Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University | Study Chair |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |