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Lung Surfactant

Infasurf Aero™ for Neonatal Respiratory Distress Syndrome (Aero-05 Trial)

Phase 3
Waitlist Available
Research Sponsored by ONY
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 1 hour AND ≤ 6 hours
Gestational age at birth ≥ 29 0/7 AND ≤ 36 6/7 weeks
Must not have
Surfactant administration prior to randomization
Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemic shock, hypoxic ischemic encephalopathy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours post birth
Awards & highlights
Pivotal Trial

Summary

This trial studies a new way to give a drug (Infasurf) to infants without a breathing tube or stopping nasal respiratory support.

Who is the study for?
This trial is for preterm newborns with a clinical diagnosis of surfactant-deficient RDS, needing non-invasive respiratory support, and weighing between 1,000 to 3,500 grams. They should be born at a gestational age of 29 to almost 37 weeks and are between 1 to 6 hours old. Newborns with airway abnormalities, prior mechanical ventilation or surfactant treatment, severe birth complications or major congenital anomalies cannot participate.
What is being tested?
The study tests the effectiveness and safety of Infasurf® delivered through InfasurfAero™ without the need for intubation in preterm newborns with RDS. It compares this novel delivery method against a sham treatment (placebo) while babies continue receiving nasal respiratory support.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions related to administering Infasurf via the new device such as irritation or discomfort in the oral airway area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a newborn, less than 6 hours old.
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My baby was born between 29 and 36 weeks of pregnancy.
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I have been diagnosed with a severe lung condition needing treatment.
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I need a machine to help me breathe without a tube.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received surfactant treatment before being assigned to a study group.
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My breathing problems are not due to newborn lung disease but another condition.
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I have a known or suspected airway problem.
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I have a bacterial infection that needs at least 5 days of antibiotics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours post birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours post birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CPAP failure and or death
Secondary study objectives
Chronic lung disease and or death
Duration of MV
Duration of non-invasive support
+4 more
Other study objectives
Adverse events during surfactant administration.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer until completion.
Group II: Control ArmPlacebo Group1 Intervention
Low flow respiratory air alone through the InfasurfAero™ Nebulizer until completion.

Find a Location

Who is running the clinical trial?

ONYLead Sponsor
8 Previous Clinical Trials
1,164 Total Patients Enrolled
AvaniaIndustry Sponsor
52 Previous Clinical Trials
9,761 Total Patients Enrolled
Jim Cummings, MDStudy DirectorOny Biotech
1 Previous Clinical Trials

Media Library

InfasurfAero™ (Lung Surfactant) Clinical Trial Eligibility Overview. Trial Name: NCT05960929 — Phase 3
Endotracheal Intubation Research Study Groups: Treatment Arm, Control Arm
Endotracheal Intubation Clinical Trial 2023: InfasurfAero™ Highlights & Side Effects. Trial Name: NCT05960929 — Phase 3
InfasurfAero™ (Lung Surfactant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05960929 — Phase 3
~37 spots leftby Jan 2025
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