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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

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

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.

0 / 1Eligibility criteria met