Status:
COMPLETED
Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia
Lead Sponsor:
Christoph Hornik
Collaborating Sponsors:
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Bronchopulmonary Dysplasia of Newborn
Eligibility:
All Genders
Up to 29 years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, placebo-controlled, sequential dose-escalating, double-masked, safety study of sildenafil in premature infants (inpatient in Neonatal Intensive Care Units (NICUs)) w...
Detailed Description
Screening/Baseline Research staff will document informed consent from the parent/guardian for all participants who satisfy eligibility criteria. The following information will be recorded in the case...
Eligibility Criteria
Inclusion
- Documented informed consent from parent or guardian, prior to study procedures
- \< 29 weeks gestational age at birth
- 32-44 weeks postmenstrual age
- Receiving respiratory support at enrollment:
- If 32 0/7-35 6/7 weeks postmenstrual age: mechanical ventilation (high frequency or conventional)
- If 36 0/7-44 6/7 weeks postmenstrual age: mechanical ventilation (high frequency or conventional) OR continuous positive airway pressure (CPAP)
- Note:
- Criteria 3 and 4 define severe BPD for the purposes of this study
- CPAP is defined as any of the following:
- Nasal cannula \> 2 liters per minute (LPM)
- Nasal continuous positive airway pressure (NCPAP)
- Nasal intermittent positive pressure ventilation (NIPPV)
- Noninvasive neurally adjusted ventilatory assist (NAVA)
- Any other device designed to provide positive pressure through a nasal device (e.g., RAM cannula, etc.)
Exclusion
- Previous enrollment and dosing in this study, protocol number (NHLBI-2019-SIL), "Safety of Sildenafil in Premature Infants with Severe Bronchopulmonary Dysplasia (BPD)"
- Previous exposure to sildenafil within 7 days prior to randomization\*
- Previous exposure to vasopressors within 24 hours prior to randomization\*
- Previous exposure to inhaled nitric oxide within 24 hours prior to randomization\*
- Previous exposure to milrinone within 24 hours prior to randomization\*
- Evidence of pulmonary hypertension or moderate/large patent ductus arteriosus (PDA) on the most recent echocardiogram performed within 14 days prior to randomization
- Known major congenital heart defect requiring medical or surgical intervention in the neonatal period
- Known allergy to sildenafil
- Known sickle cell disease
- Aspartate aminotransferase (AST) \> 225 U/L \< 72 hours prior to randomization
- Alanine aminotransferase (ALT) \> 150 U/L \< 72 hours prior to randomization
- Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study.
- Participant will be reassessed prior to dosing to reconfirm eligibility criteria.
Key Trial Info
Start Date :
May 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2025
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04447989
Start Date
May 27 2021
End Date
January 15 2025
Last Update
March 27 2025
Active Locations (25)
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1
Arkansas Children's Research Institute
Little Rock, Arkansas, United States, 72202
2
University of Arkansas Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Rady Children's Hospital and Health Center
San Diego, California, United States, 92123
4
Childrens National Medical Center
Washington D.C., District of Columbia, United States, 20010