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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks corrected gestational age
Awards & highlights

PreProMISe 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.Check my eligibility
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).See study design
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.

PreProMISe Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks corrected gestational age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks corrected gestational age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Endotracheal Intubation
Secondary outcome measures
Bronchopulmonary dysplasia

Side effects data

From 2016 Phase 3 trial • 88 Patients • NCT01709409
7%
air leak
5%
pulmonary hemorrhage
2%
pulmonary interstitial emphysema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Curosurf (Group 1)
BLES (Group 2)

PreProMISe 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.

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Who is running the clinical trial?

Chiesi USA, Inc.Industry Sponsor
8 Previous Clinical Trials
5,904 Total Patients Enrolled
NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,418 Total Patients Enrolled
4 Trials studying Premature Birth
1,623 Patients Enrolled for Premature Birth
Matthew Derrick, MBBSPrincipal InvestigatorNorthshore Univ Healthsystem
~133 spots leftby Dec 2025
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