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

A Double Blind, Randomized, Controlled Study to Compare CHF 5633 (Synthetic Surfactant) and Poractant Alfa in RDS

Sponsors

Lead sponsor: Chiesi Farmaceutici S.p.A.

Collaborator: Parexel

Source Chiesi Farmaceutici S.p.A.
Brief Summary

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 SpO2 between 88-95%.

Overall Status Completed
Start Date January 21, 2016
Completion Date May 24, 2018
Primary Completion Date May 24, 2018
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Reduced oxygen requirement and ventilatory support 7 days after treatment
Reduced oxygen requirement and ventilatory support 7 days after treatment
Bronchopulmonary dysplasia 36 weeks gestational age
Bronchopulmonary dysplasia 36 weeks gestational age
Enrollment 123
Condition
Intervention

Intervention type: Drug

Intervention name: CHF5633

Description: Rescue treatment (if needed)

Arm group label: CHF5633

Intervention type: Drug

Intervention name: Poractant alfa

Description: Rescue treatment (if needed)

Arm group label: Poractant alfa

Eligibility

Criteria:

Inclusion Criteria:

1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures

2. Inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks

3. Clinical course consistent with RDS

4. Requirement of endotracheal surfactant administration within 24 hours from birth

5. 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%

Exclusion Criteria:

1. Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)

2. Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)

3. Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy

4. Mothers with prolonged rupture of the membranes (>21 days duration)

5. Strong suspicion of congenital pneumonia/infection, sepsis

6. Presence of air leaks prior to study entry

7. Evidence of severe birth asphyxia

8. Neonatal seizures prior to study entry

9. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

10. Participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol.

Gender: All

Minimum age: N/A

Maximum age: 24 Hours

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Christiane Dammann, MD Principal Investigator Division of Newborn Medicine Floating Hospital for Children Boston USA
Location
facility
University of South Alabama - USA Children's and Women's Hospital
Good Samaritan Hospital
LAC + USC Medical Center, Keck School of Medicine
UC Irvine Medical Center
Sharp Mary Birch Hospital
Connecticut Children's Medical Center
Plantation General Hospital (Sheridan Clinical Research, Inc.)
Jatinder Bhatia
Indiana University School of Medicine
Memorial Hospital of South Bend
University of Louisville Research Foundation, Inc.
Baystate Children's Hospital / Baystate Medical Center
Winthrop University Hospital
Kings County Hospital Center
Sergio G. Golombek
Martha Naylor
Cincinnati Children's Hospital Medical Center
Case Western Reserve University
Krishnamurthy Sekar
Hahnemann University Hospital
Texas Tech University Health Sciences Center
MultiCare Institute for Research & Innovation
West Virginia University
Location Countries

United States

Verification Date

May 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: CHF5633

Arm group type: Experimental

Description: Single dose within 24 hours from birth

Arm group label: Poractant alfa

Arm group type: Active Comparator

Description: Single dose within 24 hours from birth

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov