A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)

Completed · Phase 2

Conditions studied: Respiratory Distress Syndrome, Newborn

In brief

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%.

Key facts

Study ID

NCT02452476

Run by

Chiesi Farmaceutici S.p.A.

People needed

123

Starts

2016-01-21

Expected to finish

2018-05-24

Last updated by the study team

2021-08-13

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures
• 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 SpO2 between 88-95%

You may not qualify if…

• Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
• Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)
• Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy
• Mothers with prolonged rupture of the membranes (>21 days duration)
• Strong suspicion of congenital pneumonia/infection, sepsis
• Presence of air leaks prior to study entry
• Evidence of severe birth asphyxia
• Neonatal seizures prior to study entry
• Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
• Participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol.

Where it is running

• University of South Alabama - USA Children's and Women's Hospital — Mobile, Alabama, United States
• LAC + USC Medical Center, Keck School of Medicine — Los Angeles, California, United States
• UC Irvine Medical Center — Orange, California, United States
• Sharp Mary Birch Hospital — San Diego, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Plantation General Hospital (Sheridan Clinical Research, Inc.) — Plantation, Florida, United States
• Jatinder Bhatia — Augusta, Georgia, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• University of Louisville Research Foundation, Inc. — Louisville, Kentucky, United States
• Floating Hospital for Children at Tufts Medical Center — Boston, Massachusetts, United States
• Baystate Children's Hospital / Baystate Medical Center — Springfield, Massachusetts, United States
• Winthrop University Hospital — Mineola, New York, United States
• Kings County Hospital Center — New York, New York, United States
• Sergio G. Golombek — Valhalla, New York, United States
• Martha Naylor — Greenville, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Krishnamurthy Sekar — Oklahoma City, Oklahoma, United States
• Hahnemann University Hospital — Philadelphia, Pennsylvania, United States
• Texas Tech University Health Sciences Center — El Paso, Texas, United States
• MultiCare Institute for Research & Innovation — Tacoma, Washington, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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