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Surfactant
Prophylactic Surfactant for Neonatal Respiratory Distress Syndrome (PreProMISe Trial)
Phase 4
Recruiting
Led By Matthew Derrick, MBBS
Research Sponsored by NorthShore University HealthSystem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Must not have
Alternate cause of respiratory distress
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks corrected gestational age
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test if giving premature babies surfactant at birth can improve their health outcomes compared to giving it only during a rescue treatment.
Who is the study for?
This trial is for premature infants born at 22-29 weeks' gestation. To participate, parents must give consent before birth. Infants with congenital anomalies or another cause of respiratory distress cannot join.
What is being tested?
The study tests if giving a substance called Poractant Alfa right after birth improves health outcomes compared to waiting until the baby shows signs of breathing trouble (rescue treatment).
What are the potential side effects?
Possible side effects of Poractant Alfa include blocked airways, changes in blood pressure, and oxygen levels fluctuating. These are monitored closely due to the vulnerability of preterm infants.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My breathing problems are caused by something other than my current condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 weeks corrected gestational age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks corrected gestational age
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Endotracheal Intubation
Secondary study objectives
Bronchopulmonary dysplasia
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Prophylactic Surfactant via Minimally Invasive TechniqueExperimental Treatment1 Intervention
Infants randomized to prophylactic surfactant treatment will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg as soon as possible after delivery (within 15 minutes).
Group II: Rescue Surfactant via Minimally Invasive TechniqueActive Control1 Intervention
The control group will be given surfactant will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg if their fiO2 reaches a threshold of ≥30% within the first 48 hours of life.
Find a Location
Who is running the clinical trial?
Chiesi USA, Inc.Industry Sponsor
8 Previous Clinical Trials
5,904 Total Patients Enrolled
1 Trials studying Premature Birth
60 Patients Enrolled for Premature Birth
NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,442 Total Patients Enrolled
4 Trials studying Premature Birth
1,623 Patients Enrolled for Premature Birth
Matthew Derrick, MBBSPrincipal InvestigatorNorthshore Univ Healthsystem