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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 weeks corrected gestational age

Awards & highlights

Niftisurf 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.Check my eligibility

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.See study design

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.

Niftisurf Trial 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.

Niftisurf Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of infants requiring Endotracheal Intubation

Secondary outcome measures

Duration of Supplemental oxygen

Duration of positive pressure support

Side effects data

From 2016 Phase 3 trial • 1316 Patients • NCT00233324

49%

Patent Ductus Aretriosus

21%

Death

12%

Necrotizing enterocolitis

11%

Intraventricular hemorrhage (IVH) Grade 3 or 4

Pulmonary Hemorrhage

Air leak during initial 14 days

Chest compressions or drugs in the delivery room

Nasal Breakdown

100%

80%

60%

40%

20%

Study treatment Arm

Surfactant and Lower Range Oxygen

Surfactant and Higher Range Oxygen

CPAP and Lower Range Oxygen

CPAP and Higher Range Oxygen

Niftisurf 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor

132 Previous Clinical Trials

737,396 Total Patients Enrolled

1 Trials studying Respiratory Distress Syndrome

200 Patients Enrolled for Respiratory Distress Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA authorized Calfactant (Infasurf) for use?

"The safety of Calfactant (Infasurf) is rated at a 3 due to its Phase 4 status, which indicates that it has been officially sanctioned by the relevant authorities."

Answered by AI

Has the deadline for participating in this research passed, or are new volunteers still being accepted?

"According to clinicaltrials.gov, this medical trial is no longer enrolling participants as it was initially posted on November 1st 2023 and last updated September 27th 2023. Fortunately, there are 194 other studies actively recruiting at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Non Inferiority Trial Investigating Surfactants Administered Via MIST

Matthew Derrick 2024. "Non Inferiority Trial Investigating Surfactants Administered Via MIST". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06074380.

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