CompletedNCT04447989SILDI-SAFEUpdated Jan 26, 2026Results posted

Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia

A Phase 2 interventional study of Sildenafil and Placebo in Bronchopulmonary Dysplasia of Newborn, sponsored by Christoph Hornik. Completed at 25 sites in United States. Open to participants aged Up to 29 Weeks. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by Christoph Hornik · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 125
Allocation: Randomized
Ages: Up to 29 Weeks
Sex: All

Study 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).

Read the 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 report form (eCRF) from the clinical medical record:

Participant demographics, including birth weight and gestational age at birth
Maternal race/ethnicity
Medical history
Physical examination, including actual weight
All mean arterial pressure (MAP) obtained in the 24 hours before the first dose
Concomitant medications (within 24 hours prior to start of study drug)
Respiratory assessment
Laboratory evaluations
Echocardiogram: If performed per local standard of care \< 14 days prior to start of study drug, a study-specific echocardiogram need not be repeated. If not performed per local standard of care \< 14 days prior to start of study drug, an echocardiogram will be required to confirm eligibility.
Cardiac catheterization reports, if performed per local standard of care \< 14 days prior to start of study drug.
Adverse events following initial study-specific procedure

Treatment Period

The treatment period will include Days 1-28 or last day of study drug if early withdrawal of study drug. The following information will be collected and recorded while the participant is on study drug:

Actual weight on study Days 7 (± 1 day), 14 (± 1 day), 21 (± 1 day), and 28 (± 1 day) of study drug administration
Date, time, amount, and route of study drug dose
All concomitant medications
MAP
A. All MAP values obtained 24 hours after the first dose of study drug regardless of administration route.
B. MAP values will be obtained at a minimum at the following time points i. Prior to the first dose of study drug or dose escalation: 2 hours (± 5 minutes), 1 hour (± 5 minutes), and 15 minutes (± 5 minutes) ii. If administration route is IV:
1. During and following the first dose of study drug or dose escalation: MAP at start of infusion, every 15 minutes (± 5 minutes) during infusion, at end of infusion (inclusive of flush) (± 5 minutes), at 15 and 30 minutes (± 5 minutes) after end of infusion, hourly (± 15 minutes) for 4 hours, and once in the remaining 2 hours prior to the next dose.
2. For subsequent IV doses, the lowest valid MAP value should be recorded daily while on study drug.
iii. If the administration route is enteral:
1. During and following the first dose of study drug or dose escalation: MAP at start of enteral administration, then every 15 minutes (± 5 minutes) for 90 minutes (1.5 hours), then every 30 minutes (± 5 minutes) for 60 minutes (1 hour), then hourly (± 15 minutes) for 4 hours, then once in the remaining 2 hours prior to the next dose.
2. For subsequent enteral doses, the lowest valid MAP value should be recorded daily while on study drug.
Respiratory assessment, weekly
Laboratory evaluations, at least every other week
Echocardiograms and cardiac catheterization reports, if performed per local standard of care
Pharmacokinetic (PK) sampling (after Day 7)
Adverse events

Weaning Period (Cohorts 2 and 3)

The weaning period will begin following Day 28 of study drug or, following the last day of study drug if participant was withdrawn from study drug prior to Day 28 and the dose escalated to ≥ 0.5 mg/kg IV or ≥ 1 mg/kg enteral.

The following information will be collected and recorded while the participant is weaning from study drug:

Date, time, amount and route of study drug dose
MAP (the lowest MAP value on last day of wean should be recorded).
Respiratory assessment on last day of wean
Echocardiogram and cardiac catheterization reports, if performed per local standard of care
Adverse events

Follow-up Period

The follow-up period will include Days 1-28 after the last study drug dose; last study drug dose may occur prior to Day 28 for those participants who withdraw from study drug early; on Day 28 for those participants who complete the full treatment period; or after last weaning dose for those participants who require weaning. The following information will be reported in electronic data capture system (EDC) at Day 1 (+ 2 days) and 14 (± 2days) of the follow-up period (or days closest to and after Day 1 and 14, if >1 assessment is available), except for MAP, adverse events (AEs), and serious adverse events (SAEs) (which will be reported from Days 1-28 post last study drug dose) and standard of care echocardiograms or cardiac catheterization reports:

Physical examination, including actual weight
MAP (the lowest valid MAP value on follow-up Day 1, 14, 21, and 28 should be recorded).
Respiratory assessment
Laboratory evaluations
Echocardiogram on follow-up Day 1 (+2 days). If performed per local standard of care, a study-specific echocardiogram need not be repeated. If not performed per local standard of care on Day 1 (+2 days) of the follow-up period, an echocardiogram will need to be performed.
Echocardiograms and cardiac catheterization reports, if performed per local standard of care (during follow-up Days 1-28)
Adverse events and SAEs (during follow-up Days 1-28)

Final Study Assessment

Final study assessment will occur at the time of discharge or transfer. The following information will be collected:

Physical examination, including actual weight
Respiratory assessment
Echocardiogram and cardiac catheterization reports, if performed per local standard of care on the day of discharge or transfer or up to 2 days prior.
Global rank
Discharge information A. Discharge or transfer B. Death C. Duration of hospitalization
Record if treatment for retinopathy of prematurity (ROP) was required

Conditions studied

Bronchopulmonary Dysplasia of Newborn

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Bronchopulmonary Dysplasia 339

In context

Bronchopulmonary Dysplasia

339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.

This study's enrollment of 125 is above the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.

Browse Bronchopulmonary Dysplasia studies →

Lead sponsor

This is the only study on the registry with Christoph Hornik as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 29 Weeks
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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 criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 125 participants (actual)

Study arms

Active comparator
Cohort 1, sildenafil
Sildenafil (0.5 mg/kg IV or 1 mg/kg enteral) every 8 hours for 28 days
Drug: Sildenafil
Placebo comparator
Cohort 1, placebo
Placebo (IV or enteral) every 8 hours for 28 days
Drug: Placebo
Active comparator
Cohort 2, sildenafil
Sildenafil (1 mg/kg IV or 2 mg/kg enteral) every 8 hours for 28 days
Drug: Sildenafil
Placebo comparator
Cohort 2, placebo
Placebo (IV or enteral) every 8 hours for 28 days
Drug: Placebo
Active comparator
Cohort 3, sildenafil
Sildenafil (2 mg/kg IV or 4 mg/kg enteral) every 8 hours for 28 days
Drug: Sildenafil
Placebo comparator
Cohort 3, placebo
Placebo (IV or enteral) every 8 hours for 28 days
Drug: Placebo

Interventions

DrugSildenafil
Sildenafil citrate injection or powder for suspension
Also known as: Revatio
DrugPlacebo
dextrose 5%
Also known as: Dextrose 5%

What researchers measure

Primary outcomes

Safety Based Upon Number of Participants With Hypotension
Safety as determined by incidence of hypotension experienced by the participants through 28 days post last dose of study drug. Hypotension will be defined as any clinically significant low blood pressure event deemed by the treating physician to require intervention with a fluid bolus or the initiation or escalation of inotropic, vasopressor, or systemic steroid therapy with the specific intent to raise blood pressure.
Time frame: 28 days post last dose of study drug, up to 9 weeks

Secondary outcomes

Central Volume of Distribution (Vc) Population Pharmacokinetics (popPK)
Time frame: Following the completion of 7 days (168 hours) of study drug administration
Peripheral Volume of Distribution (Vp) Population Pharmacokinetics (popPK)
Time frame: Following the completion of 7 days (168 hours) of study drug administration
Clearance Population Pharmacokinetics (popPK)
Time frame: Following the completion of 7 days (168 hours) of study drug administration
Half-life Population Pharmacokinetics (popPK)
Time frame: Following the completion of 7 days (168 hours) of study drug administration
Peak Plasma Concentration Population Pharmacokinetics (popPK)
Time frame: Following the completion of 7 days (168 hours) of study drug administration

Other outcomes

Number of Participants at Each Global Rank
Global rank is defined as clinically significant events ranked in order of decreasing perceived severity. Rank descriptions are presented from most to least severe.
Time frame: 28 days post last dose of study drug, up to 9 weeks

Results

Posted Jan 26, 2026

Participant flow

Participant flow — Overall Study
Milestone	Cohort 1, Sildenafil	Cohort 2, Sildenafil	Cohort 3, Sildenafil	Placebo
Started	32	30	32	31
Completed	31	27	31	26
Not completed	1	3	1	5
Withdrew: Withdrawal by subject	1	1	0	0
Withdrew: Physician decision	0	0	0	1
Withdrew: Transfer	0	1	0	0
Withdrew: Discharge	0	1	1	3
Withdrew: Ineligibility	0	0	0	1

Outcome measures

PrimarySafety Based Upon Number of Participants With Hypotension

Safety as determined by incidence of hypotension experienced by the participants through 28 days post last dose of study drug. Hypotension will be defined as any clinically significant low blood pressure event deemed by the treating physician to require intervention with a fluid bolus or the initiation or escalation of inotropic, vasopressor, or systemic steroid therapy with the specific intent to raise blood pressure.

Time frame:: 28 days post last dose of study drug, up to 9 weeks
Reported as:: Count of participants · Participants

Safety Based Upon Number of Participants With Hypotension
Participants	Cohort 1, Sildenafil	Cohort 2, Sildenafil	Cohort 3, Sildenafil	Placebo
Safety Based Upon Number of Participants With Hypotension	1	0	0	0

SecondaryCentral Volume of Distribution (Vc) Population Pharmacokinetics (popPK)

Time frame:: Following the completion of 7 days (168 hours) of study drug administration
Reported as:: Median · L

Central Volume of Distribution (Vc) Population Pharmacokinetics (popPK)
L	Pharmacokinetics (PK) Cohort
Central Volume of Distribution (Vc) Population Pharmacokinetics (popPK)	3.86 (1.28 to 11.07)

SecondaryPeripheral Volume of Distribution (Vp) Population Pharmacokinetics (popPK)

Time frame:: Following the completion of 7 days (168 hours) of study drug administration
Reported as:: Median · L

Peripheral Volume of Distribution (Vp) Population Pharmacokinetics (popPK)
L	Pharmacokinetics (PK) Cohort
Peripheral Volume of Distribution (Vp) Population Pharmacokinetics (popPK)	4.49 (2.87 to 6.66)

SecondaryClearance Population Pharmacokinetics (popPK)

Time frame:: Following the completion of 7 days (168 hours) of study drug administration
Reported as:: Median · L/h

Clearance Population Pharmacokinetics (popPK)
L/h	Pharmacokinetics (PK) Cohort
Clearance Population Pharmacokinetics (popPK)	2.69 (1.00 to 7.94)

SecondaryHalf-life Population Pharmacokinetics (popPK)

Time frame:: Following the completion of 7 days (168 hours) of study drug administration
Reported as:: Median · hours

Half-life Population Pharmacokinetics (popPK)
hours	Pharmacokinetics (PK) Cohort
Half-life Population Pharmacokinetics (popPK)	8.79 (8.00 to 9.42)

SecondaryPeak Plasma Concentration Population Pharmacokinetics (popPK)

Time frame:: Following the completion of 7 days (168 hours) of study drug administration
Reported as:: Median · ng/mL

Peak Plasma Concentration Population Pharmacokinetics (popPK)
ng/mL	Pharmacokinetics (PK) Cohort
Peak Plasma Concentration Population Pharmacokinetics (popPK)	130.5 (70.9 to 256.0)

Other pre-specifiedNumber of Participants at Each Global Rank

Global rank is defined as clinically significant events ranked in order of decreasing perceived severity. Rank descriptions are presented from most to least severe.

Time frame:: 28 days post last dose of study drug, up to 9 weeks
Reported as:: Count of participants · Participants

Number of Participants at Each Global Rank
Participants	Cohort 1, Sildenafil	Cohort 2, Sildenafil	Cohort 3, Sildenafil	Placebo
Mortality	0	2	1	0
Extracorporeal life support	0	0	0	0
Tracheostomy	8	3	4	9
Periventricular leukomalacia (PVL)	1	1	0	0
Seizures	1	2	1	1
Dialysis	0	0	0	0
Retinopathy of prematurity (ROP)	13	11	18	12
Short gut syndrome/intestinal failure	0	0	0	0
Ventriculoperitoneal (VP) shunt	0	0	0	0
Gastrostomy tube	4	2	3	1
Surgical necrotizing enterocolitis/intestinal perforation (NEC/IP)	0	0	0	0
Patent ductus arteriosus (PDA)	0	1	2	2
Meningitis	0	0	0	0
Sepsis	0	1	0	0
Duration of hospitalization >= 52 weeks PMA	0	0	0	0
Duration of hospitalization 48 - 51 weeks PMA	1	3	0	0
Duration of hospitalization 44 - 47 weeks PMA	1	2	1	2
Duration of hospitalization 40 - 43 weeks PMA	2	1	2	2
Duration of hospitalization 36 - 39 weeks PMA	0	0	0	1

Adverse events

Collected over Up to 28 days post last dose of study drug, up to 9 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1, Sildenafil	0/31 (0%)	3/31 (9.7%)	—
Cohort 2, Sildenafil	2/29 (6.9%)	0/29 (0%)	—
Cohort 3, Sildenafil	1/32 (3.1%)	4/32 (12.5%)	—
Placebo	0/30 (0%)	4/30 (13.3%)	—

Most frequent serious events

Showing 10 of 13

Most frequent serious events
Event	Cohort 1, Sildenafil	Cohort 2, Sildenafil	Cohort 3, Sildenafil	Placebo
Retinopathy of prematurityEye disorders	2/31	0/29	0/32	1/30
Meningitis bacterialInfections and infestations	0/31	0/29	0/32	1/30
Streptococcal sepsisInfections and infestations	0/31	0/29	0/32	1/30
Urinary tract infectionInfections and infestations	0/31	0/29	0/32	1/30
Urinary tract infection enterococcalInfections and infestations	0/31	0/29	0/32	1/30
Weaning failureInjury, poisoning and procedural complications	0/31	0/29	0/32	1/30
SeizureNervous system disorders	0/31	0/29	0/32	1/30
BronchospasmRespiratory, thoracic and mediastinal disorders	1/31	0/29	0/32	0/30
Pneumonia bacterialInfections and infestations	0/31	0/29	1/32	0/30
SepsisInfections and infestations	0/31	0/29	1/32	0/30

Baseline characteristics

Intent to Treat (ITT) population

Age, Customized
Age, Customized(weeks)	Cohort 1, Sildenafil	Cohort 2, Sildenafil	Cohort 3, Sildenafil	Placebo	Total
Gestational age	25.16 ± 1.46	25.49 ± 1.70	25.40 ± 1.59	25.45 ± 1.76	25.37 ± 1.61
Postnatal age	13.21 ± 3.44	12.44 ± 3.12	11.96 ± 3.54	12.48 ± 3.43	12.53 ± 3.38
Post-menstrual age	38.37 ± 2.84	37.94 ± 3.19	37.37 ± 2.73	37.94 ± 3.27	37.90 ± 3.00

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort 1, Sildenafil	Cohort 2, Sildenafil	Cohort 3, Sildenafil	Placebo	Total
Female	17	17	16	9	59
Male	15	12	16	22	65

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cohort 1, Sildenafil	Cohort 2, Sildenafil	Cohort 3, Sildenafil	Placebo	Total
Hispanic or Latino	2	0	2	1	5
Not Hispanic or Latino	28	28	27	27	110
Unknown or Not Reported	2	1	3	3	9

Region of Enrollment
Region of Enrollment(Participants)	Cohort 1, Sildenafil	Cohort 2, Sildenafil	Cohort 3, Sildenafil	Placebo	Total
United States	32	29	32	31	124

Study locations

25 sites

Arkansas Children's Research Institute
Little Rock, Arkansas 72202, United States
University of Arkansas Medical Sciences
Little Rock, Arkansas 72205, United States
Rady Children's Hospital and Health Center
San Diego, California 92123, United States
Childrens National Medical Center
Washington D.C., District of Columbia 20010, United States
University of Florida Jacksonville Shands Medical Center
Jacksonville, Florida 32209, United States
Wolfson Children's Hospital
Jacksonville, Florida 32209, United States
Emory Children's Center
Atlanta, Georgia 30322, United States
Lurie Children's Hospital
Chicago, Illinois 60611-2605, United States
University of Illinois at Chicago
Chicago, Illinois 60611, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky 40506, United States
University of Louisville School of Medicine
Louisville, Kentucky 40202, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana 70115, United States
Boston Children's Hospital
Boston, Massachusetts 02115, United States
University of Mississippi Medical Center
Jackson, Mississippi 39216, United States
Childrens Mercy Hospital
Kansas City, Missouri 64108, United States
Children's Hospital of Nevada at University Medical Center
Las Vegas, Nevada 89102, United States
University of Rochester School of Medicine Children's Hospital
Rochester, New York 14642, United States
Westchester Medical Center - New York Medical College
Valhalla, New York 10595, United States
University of NC at Chapel Hill
Chapel Hill, North Carolina 27599, United States
East Carolina University
Greenville, North Carolina 27858, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio 44106, United States
University of Tennessee Health Science Center
Memphis, Tennessee 38163, United States
University of Texas Health
Austin, Texas 78723, United States
Women's Hospital of Texas
Houston, Texas 77054, United States

References and documents

Publications

Gonzalez D, Laughon MM, Smith PB, Ge S, Ambalavanan N, Atz A, Sokol GM, Hornik CD, Stewart D, Mundakel G, Poindexter BB, Gaedigk R, Mills M, Cohen-Wolkowiez M, Martz K, Hornik CP; Best Pharmaceuticals for Children Act - Pediatric Trials Network Steering Committee. Population pharmacokinetics of sildenafil in extremely premature infants. Br J Clin Pharmacol. 2019 Dec;85(12):2824-2837. doi: 10.1111/bcp.14111. Epub 2019 Dec 15. PubMed 31475367 ↗
Stoll BJ, Hansen NI, Bell EF, Walsh MC, Carlo WA, Shankaran S, Laptook AR, Sanchez PJ, Van Meurs KP, Wyckoff M, Das A, Hale EC, Ball MB, Newman NS, Schibler K, Poindexter BB, Kennedy KA, Cotten CM, Watterberg KL, D'Angio CT, DeMauro SB, Truog WE, Devaskar U, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012. JAMA. 2015 Sep 8;314(10):1039-51. doi: 10.1001/jama.2015.10244. PubMed 26348753 ↗
Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available. PubMed 11401896 ↗
Khemani E, McElhinney DB, Rhein L, Andrade O, Lacro RV, Thomas KC, Mullen MP. Pulmonary artery hypertension in formerly premature infants with bronchopulmonary dysplasia: clinical features and outcomes in the surfactant era. Pediatrics. 2007 Dec;120(6):1260-9. doi: 10.1542/peds.2007-0971. PubMed 18055675 ↗
Morrow CB, McGrath-Morrow SA, Collaco JM. Predictors of length of stay for initial hospitalization in infants with bronchopulmonary dysplasia. J Perinatol. 2018 Sep;38(9):1258-1265. doi: 10.1038/s41372-018-0142-7. Epub 2018 Jun 8. PubMed 29880793 ↗
Jackson W, Hornik CP, Messina JA, Guglielmo K, Watwe A, Delancy G, Valdez A, MacArthur T, Peter-Wohl S, Smith PB, Tolia VN, Laughon MM. In-hospital outcomes of premature infants with severe bronchopulmonary dysplasia. J Perinatol. 2017 Jul;37(7):853-856. doi: 10.1038/jp.2017.49. Epub 2017 Apr 6. PubMed 28383537 ↗
Poets CF, Lorenz L. Prevention of bronchopulmonary dysplasia in extremely low gestational age neonates: current evidence. Arch Dis Child Fetal Neonatal Ed. 2018 May;103(3):F285-F291. doi: 10.1136/archdischild-2017-314264. Epub 2018 Jan 23. PubMed 29363502 ↗
Tyson JE, Wright LL, Oh W, Kennedy KA, Mele L, Ehrenkranz RA, Stoll BJ, Lemons JA, Stevenson DK, Bauer CR, Korones SB, Fanaroff AA. Vitamin A supplementation for extremely-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network. N Engl J Med. 1999 Jun 24;340(25):1962-8. doi: 10.1056/NEJM199906243402505. PubMed 10379020 ↗
Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W; Caffeine for Apnea of Prematurity Trial Group. Caffeine therapy for apnea of prematurity. N Engl J Med. 2006 May 18;354(20):2112-21. doi: 10.1056/NEJMoa054065. PubMed 16707748 ↗
Doyle LW, Ehrenkranz RA, Halliday HL. Early (< 8 days) postnatal corticosteroids for preventing chronic lung disease in preterm infants. Cochrane Database Syst Rev. 2014 May 13;(5):CD001146. doi: 10.1002/14651858.CD001146.pub4. PubMed 24825456 ↗
Jackson WM, Foote HP, Stephenson N, Kemp SM, Moore RT, Nitkin CR, Stewart D, Pryhuber GS, Berger JT, Shukla A, England A, Ford SM, Parton LA, Check JF, Hanna MH, Lagoski M, Krishnan R, Leeman KT, Vyas-Read S, Hudak ML, Katheria AC, Pillers DM, Ji J, Banfro F, Nelin LD, McCulloch M, Ahmad K, Laughon MM, Hornik CP; SILDI-SAFE Study Group. Safety of Sildenafil in Premature Infants with Severe Bronchopulmonary Dysplasia (SILDI-SAFE): A Randomized Controlled Trial. J Pediatr. 2026 Aug;295:115147. doi: 10.1016/j.jpeds.2026.115147. Epub 2026 May 7. PubMed 42105936 ↗
Schneider S, Bailey M, Spears T, Esther CR Jr, Laughon MM, Hornik CP, Jackson W. Safety of sildenafil in premature infants with severe bronchopulmonary dysplasia (SILDI-SAFE): a multicenter, randomized, placebo-controlled, sequential dose-escalating, double-masked, safety study. BMC Pediatr. 2020 Dec 14;20(1):559. doi: 10.1186/s12887-020-02453-7. PubMed 33317479 ↗

Study documents

Protocol and statistical analysis plan · Mar 8, 2022
Informed consent form · Mar 27, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — There is no plan to make IPD available to other researchers

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04447989
Lead sponsor: Christoph Hornik
Collaborators: University of North Carolina, Chapel Hill, National Heart, Lung, and Blood Institute (NHLBI)
Responsible party: Christoph Hornik (Associate Professor of Pediatrics, Duke University) — Sponsor-investigator
First posted: Jun 25, 2020
Start date: May 27, 2021
Primary completion: Dec 12, 2024
Completion: Jan 15, 2025
Results posted: Jan 26, 2026
Last update: Jan 26, 2026

Study contacts

Christoph Hornik, MD

principal investigator · Duke UMC

Matt Laughon, MD

principal investigator · UNC

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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