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Surfactant

Surfactant Therapy for Neonatal Respiratory Distress Syndrome (Niftisurf Trial)

Phase 4

Recruiting

Research Sponsored by NorthShore University HealthSystem

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome confirmed by a chest x-ray on nasal continuous positive airway pressure (NCPAP) and FiO2 ≥0.30

Be younger than 18 years old

Must not have

Infants who require emergent intubation will not be enrolled in the interventions.

Infants will be excluded if there is a congenital anomaly or an alternative cause for 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 studies preterm babies w/respiratory distress syndrome, randomized to either Curosurf or Infasurf to see which works best. Exclusions: Congenital anomalies, other causes of distress, & emergent intubation. Parental consent required.

Who is the study for?

This trial is for preterm infants between 28 and almost 36 weeks old, diagnosed with respiratory distress syndrome within their first 48 hours of life. They must be on nasal continuous positive airway pressure (NCPAP) with a certain level of oxygen need. Babies with congenital anomalies or other causes for respiratory distress, or those needing emergency intubation are not eligible.

What is being tested?

The study is testing the effectiveness of administering surfactants through Minimally Invasive Surfactant Therapy (MIST) in treating neonatal respiratory distress syndrome. It's a multicenter trial where babies will randomly receive either curosuf or infasurf via MIST to see if one is not worse than the other.

What are the potential side effects?

While specific side effects are not listed here, generally, surfactant administration can cause temporary breathing difficulties, changes in heart rate or blood pressure, blockage of the airways by mucus plugs, and rarely an allergic reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My preterm infant has respiratory distress syndrome, confirmed by chest x-ray, needs NCPAP and FiO2 ≥0.30.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My infant does not require emergency breathing support.

Select...

My infant does not have a birth defect causing breathing problems.

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

Number of infants requiring Endotracheal Intubation

Secondary study objectives

Duration of Supplemental oxygen

Duration of positive pressure support

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

Group I: Poractant alfa (Curosurf)Experimental Treatment1 Intervention

Neonate, 28-35 weeks gestation, less than 48 hours of age, with respiratory distress syndrome on CPAP \> 30% oxygen will be given 2.5ml/kg of Poractant alfa.

Group II: Calfactant (Infasurf)Experimental Treatment1 Intervention

Neonate, 28-35 weeks gestation, less than 48 hours of age, with respiratory distress syndrome on CPAP \> 30% oxygen will be given 3ml/kg of Calfacant

0 / 3Eligibility criteria met