You are viewing an expired study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials

Hartford, Connecticut

  • Respiratory Distress Syndrome, Newborn

Purpose:

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%.


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.


Study is Available At:


Original ID:

CCD-05633AA1-02


NCT ID:

NCT02452476


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

24 Hours


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Chiesi Farmaceutici S.p.A.


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

123


Enrollment Type:

Actual


Overall Contact Information

Official Name:Christiane Dammann, MD
Principal Investigator
Division of Newborn Medicine Floating Hospital for Children Boston USA

Study Dates

Start Date:January 21, 2016
Completion Date:May 24, 2018
Completion Type:Actual
Primary Completion Date:May 24, 2018
Primary Completion Type:Actual
Verification Date:May 2019
Last Changed Date:May 15, 2019
First Received Date:May 20, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Bronchopulmonary dysplasia
Time Frame:36 weeks gestational age
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Reduced oxygen requirement and ventilatory support
Time Frame:7 days after treatment
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:CHF5633
Description:Rescue treatment (if needed)
Arm Name:CHF5633
Intervention Type:Drug
Name:Poractant alfa
Description:Rescue treatment (if needed)
Arm Name:Poractant alfa

Study Arms

Study Arm Type:Experimental
Arm Name:CHF5633
Description:Single dose within 24 hours from birth
Study Arm Type:Active Comparator
Arm Name:Poractant alfa
Description:Single dose within 24 hours from birth

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Chiesi Farmaceutici S.p.A.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Parexel

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.