Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia

Completed · Phase 2 · Has a placebo group

Conditions studied: Bronchopulmonary Dysplasia of Newborn

In brief

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)) with severe bronchopulmonary dysplasia (BPD).

Key facts

Study ID

NCT04447989

Run by

Christoph Hornik

People needed

125

Starts

2021-05-27

Expected to finish

2025-01-15

Last updated by the study team

2026-01-26

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• Arkansas Children's Research Institute — Little Rock, Arkansas, United States
• University of Arkansas Medical Sciences — Little Rock, Arkansas, United States
• Rady Children's Hospital and Health Center — San Diego, California, United States
• Childrens National Medical Center — Washington D.C., District of Columbia, United States
• University of Florida Jacksonville Shands Medical Center — Jacksonville, Florida, United States
• Wolfson Children's Hospital — Jacksonville, Florida, United States
• Emory Children's Center — Atlanta, Georgia, United States
• Lurie Children's Hospital — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• University of Louisville School of Medicine — Louisville, Kentucky, United States
• Ochsner Baptist Medical Center — New Orleans, Louisiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Childrens Mercy Hospital — Kansas City, Missouri, United States
• Children's Hospital of Nevada at University Medical Center — Las Vegas, Nevada, United States
• University of Rochester School of Medicine Children's Hospital — Rochester, New York, United States
• Westchester Medical Center - New York Medical College — Valhalla, New York, United States
• University of NC at Chapel Hill — Chapel Hill, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Rainbow Babies and Childrens Hospital — Cleveland, Ohio, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States
• University of Texas Health — Austin, Texas, United States
• Women's Hospital of Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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