Bronchopulmonary Dysplasia (BPD) Clinical Trial
— SASSIEOfficial title:
Steroids and Surfactant in Extremely Low Gestation Age Infants Pilot Dose Escalation Trial
Verified date | October 2018 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a phase I/II open-label study to determine the lowest, safe, effective dose of budesonide given with calfactant as the vehicle.
Status | Completed |
Enrollment | 25 |
Est. completion date | April 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 14 Days |
Eligibility |
Inclusion Criteria: 1. > 23 0/7 and < 27 6/7 weeks of gestational age based on center's best estimate of due date (using earliest obstetrical ultrasound, last menstrual period, examination, and other pertinent available information) 2. Day of life 3-14 from the date and time of delivery, with the date of birth being DOL 0 3. Intubated and mechanically ventilated and do not anticipate extubation in next 24 hours Exclusion Criteria: 1. Serious congenital malformations or chromosomal abnormality 2. Likely to be extubated in next 24 hours 3. Clinically unstable 4. Infants who have received systemic steroids prior to dosing with study medication. 5. Infants who have received Indocin, Ibuprofen, or acetaminophen = 96 hours prior to enrollment window ending |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida, Jacksonville | Jacksonville | Florida |
United States | Vanderbilt Children's Hospital | Nashville | Tennessee |
United States | Florida Hospital for Children | Orlando | Florida |
United States | Oregon Health ans Science University | Portland | Oregon |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Cynthia McEvoy | Florida Hospital for Children, Thrasher Research Fund, University of California, San Francisco, University of Florida |
United States,
Barrette AM, Roberts JK, Chapin C, Egan EA, Segal MR, Oses-Prieto JA, Chand S, Burlingame AL, Ballard PL. Antiinflammatory Effects of Budesonide in Human Fetal Lung. Am J Respir Cell Mol Biol. 2016 Nov;55(5):623-632. — View Citation
Roberts JK, Stockmann C, Dahl MJ, Albertine KH, Egan E, Lin Z, Reilly CA, Ballard PL, Ballard RA, Ward RM. Pharmacokinetics of Budesonide Administered with Surfactant in Premature Lambs: Implications for Neonatal Clinical Trials. Curr Clin Pharmacol. 2016;11(1):53-61. — View Citation
Yeh TF, Chen CM, Wu SY, Husan Z, Li TC, Hsieh WS, Tsai CH, Lin HC. Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia. Am J Respir Crit Care Med. 2016 Jan 1;193(1):86-95. doi: 10.1164/rccm.201505-0861OC. — View Citation
Yeh TF, Lin HC, Chang CH, Wu TS, Su BH, Li TC, Pyati S, Tsai CH. Early intratracheal instillation of budesonide using surfactant as a vehicle to prevent chronic lung disease in preterm infants: a pilot study. Pediatrics. 2008 May;121(5):e1310-8. doi: 10.1542/peds.2007-1973. Epub 2008 Apr 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The clinical and anti-inflammatory efficacy of escalating doses of budesonide suspended in calfactant and given into the lungs of ELGANs by monitoring respiratory severity score (RSS). | Dose escalation will be defined as effective at the dose level in which 5 of 8 infants achieve the following: Extubation within 72 hours of first dose or after < 3 doses-without re-intubation before 28 days of age RSS on nasal continuous positive airway pressure (NCPAP) < 1.5 or on nasal cannula Fi02 <25% at < 2L/min at 28 days of age, persisting for at least 72 hours. Cumulative supplemental oxygen < 4.2 from time of enrollment to 28 days of age 4 (see calculation below) No respiratory support at 28 days, including no supplemental oxygen by nasal cannula AND a > 50% suppression of the tracheal aspirate interleukin-8 (IL-8) or CCL2 (chemokine ligand 2) at 24-72 hours (or prior to extubation if occurs at <24 hours after dosing) after the initial dose in 5 of 8 of the infants (this may be a different combination of 5 patients than those who met the above criteria). |
28 days of life for each dosing group | |
Primary | The clinical and anti-inflammatory efficacy of escalating doses of budesonide suspended in calfactant and given into the lungs of ELGANs by monitoring tracheal aspirate cytokine levels. | B. AND a > 50% suppression of the tracheal aspirate interleukin-8 or chemokine ligand 2 at 24-72 hours (or prior to extubation if occurs at <24 hours after dosing) after the initial dose in 5 of 8 of the infants | 28 days of life for each dosing group | |
Secondary | Adverse Events/Subject Safety | Safety assessments will include the subject's vital signs, clinical laboratory testing, morbidities associated with prematurity, morbidities associated with administration of budesonide in calfactant, and Adverse Events (AE)s. Clinical parameters/ AEs of interest are those potentially consistent with elevated glucocorticoid levels and will be specifically evaluated. A Data and Safety Monitoring Board (DSMB) will be established to review safety data. All of the data will be reviewed to monitor subject safety. | Through 28 days of life | |
Secondary | Serial Budesonide Levels | The research team will obtain dried blood spot samples at 15 minutes, and 1 and 4 hours after the first dose of budesonide in calfactant for budesonide levels. Trough concentrations (Cmin) will be drawn before potential subsequent daily doses. | At 15 minutes, 1 and 4 hours after first dose and prior to each additional dose | |
Secondary | Mean Airway Pressure and Oxygen Requirement at 28 Days of Age | Clinical respiratory status (RSS and oxygen requirement) around dosing and at 28 days of age will be compared between dosing groups and also compared to the matched historical control patients from the "Trial of Late Surfactant:(TOLSURF) study. | 28 days of life for each dosing group | |
Secondary | Mean Airway Pressure and Oxygen Requirement Correlated to Budesonide levels | The individual patient's decrease in RSS will be correlated with their budesonide exposure measures by the area under the concentration time curve (AUC). | 28 days of life for each dosing group |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06409299 -
Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: Azithromycin (AZI) for Airway Infection Prevention
|
Phase 3 | |
Completed |
NCT01223287 -
Physiologic Definition of Bronchopulmonary Dysplasia
|
N/A | |
Completed |
NCT00067613 -
Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
|
N/A | |
Completed |
NCT00349726 -
Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants
|
Phase 2 | |
Completed |
NCT02128191 -
No Treatment Versus Oral Ibuprofen Treatment for Patent Ductus Arteriosus in Preterm Infants
|
Phase 2 | |
Completed |
NCT01516398 -
Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia
|
||
Completed |
NCT04756297 -
Lung Ultrasound for Prediction of Bronchopulmonary Dysplasia
|
||
Completed |
NCT01030575 -
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
|
Phase 2 | |
Completed |
NCT02163681 -
MRI for Non-Invasive Imaging in Neonates and Children
|
N/A | |
Active, not recruiting |
NCT01702805 -
Transfusion of Prematures Trial
|
Phase 3 | |
Active, not recruiting |
NCT04545866 -
The Budesonide in Babies (BiB) Trial
|
Phase 3 |