A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)
Public ClinicalTrials.gov record NCT02452476. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A DOUBLE BLIND, RANDOMIZED, CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF SYNTHETIC SURFACTANT (CHF 5633) IN COMPARISON TO PORCINE SURFACTANT (PORACTANT ALFA, CUROSURF®) IN THE TREATMENT OF PRETERM NEONATES WITH RESPIRATORY DISTRESS SYNDROME
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A multicenter, double blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with respiratory distress syndrome. Main objectives of this study are to investigate the short term efficacy profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf®) in terms of reduced oxygen requirement and ventilatory support and to evaluate the mid-term efficacy profile in terms of reduced incidence of bronchopulmonary dysplasia (BPD) and mortality/BPD rate at 36 weeks post menstrual age (PMA), mortality rate at 28 days and 36 weeks PMA, RDS-associated mortality through 14 days of age and other major co-morbidities of prematurity. Inclusion criteria are: Written parental informed consent, inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with RDS, requirement of endotracheal surfactant administration within 24 hours from birth, fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for babies 27+0 to 29+6 weeks to maintain arterial oxygen saturation by pulse oximetry (SpO2) between 88-95%.
Study identification
- NCT ID
- NCT02452476
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 123 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Hour to 24 Hours
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 21, 2016 (Actual)
- Primary completion
- May 24, 2018 (Actual)
- Completion
- May 24, 2018 (Actual)
- Last update posted
- Aug 13, 2021
2016 – 2018
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama - USA Children's and Women's Hospital | Mobile | Alabama | — | — |
| LAC + USC Medical Center, Keck School of Medicine | Los Angeles | California | — | — |
| UC Irvine Medical Center | Orange | California | — | — |
| Sharp Mary Birch Hospital | San Diego | California | — | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | — | — |
| Plantation General Hospital (Sheridan Clinical Research, Inc.) | Plantation | Florida | — | — |
| Jatinder Bhatia | Augusta | Georgia | — | — |
| Indiana University School of Medicine | Indianapolis | Indiana | — | — |
| Memorial Hospital of South Bend | South Bend | Indiana | — | — |
| University of Louisville Research Foundation, Inc. | Louisville | Kentucky | — | — |
| Floating Hospital for Children at Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Baystate Children's Hospital / Baystate Medical Center | Springfield | Massachusetts | — | — |
| Winthrop University Hospital | Mineola | New York | — | — |
| Kings County Hospital Center | New York | New York | — | — |
| Sergio G. Golombek | Valhalla | New York | — | — |
| Martha Naylor | Greenville | North Carolina | — | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | — | — |
| Case Western Reserve University | Cleveland | Ohio | — | — |
| Krishnamurthy Sekar | Oklahoma City | Oklahoma | — | — |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | — | — |
| Texas Tech University Health Sciences Center | El Paso | Texas | — | — |
| MultiCare Institute for Research & Innovation | Tacoma | Washington | — | — |
| West Virginia University | Morgantown | West Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02452476, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2021 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02452476 live on ClinicalTrials.gov.