Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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)) with severe bronchopulmonary dysplasia (BPD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christoph P Hornik, MD MPH
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of North Carolina, Chapel Hill
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

1. Documented informed consent from parent or guardian, prior to study procedures

2. < 29 weeks gestational age at birth

3. 32-40 weeks postmenstrual age

4. Receiving respiratory support at enrollment:

• If 32-36 weeks postmenstrual age: mechanical ventilation (high frequency or conventional)

• If > 36-40 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 Criteria:

1. Previous enrollment and dosing in this study, protocol number (NHLBI-2019-SIL), "Safety of Sildenafil in Premature Infants with Severe Bronchopulmonary Dysplasia (BPD)"

2. Previous exposure to sildenafil within 7 days prior to randomization*

3. Previous exposure to vasopressors within 24 hours prior to randomization*

4. Previous exposure to inhaled nitric oxide within 24 hours prior to randomization

5. Evidence of pulmonary hypertension or moderate/large patent ductus arteriosus (PDA) on the most recent echocardiogram performed within 14 days prior to randomization

6. Known major congenital heart defect requiring medical or surgical intervention in the neonatal period

7. Known allergy to sildenafil

8. Known sickle cell disease

9. Aspartate aminotransferase (AST) > 225 U/L < 72 hours prior to randomization

10. Alanine aminotransferase (ALT) > 150 U/L < 72 hours prior to randomization

11. 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.