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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours post birth
Awards & highlights

Aero-05 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.Check my eligibility
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.See study design
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.

Aero-05 Trial 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.

Aero-05 Trial 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

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

Aero-05 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
46 Previous Clinical Trials
8,678 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
Neonatal Death Research Study Groups: Treatment Arm, Control Arm
Neonatal Death 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

Frequently Asked Questions

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

Is the age threshold for this study set above 75 years of age?

"This clinical trial's inclusion criteria stipulate that only patients aged 29 Weeks to 36 Weeks are eligible. Moreover, 69 trials for those below 18 and 150 studies targeting elderly individuals exist."

Answered by AI

Has Treatment Arm received endorsement from the FDA?

"With a score of 3, Treatment Arm is deemed relatively safe due to the existence of efficacy and safety data from prior clinical trials."

Answered by AI

Are there any available positions for prospective participants in this research endeavor?

"According to the records on clinicaltrials.gov, this particular trial is no longer actively recruiting participants having been posted initially on October 1st 2023 and last updated July 25th 2023. Nevertheless, there are currently 208 other trials that are seeking patients for enrollment."

Answered by AI

How many medical centers are conducting this research?

"At present, this trial has 6 recruiting centres including Saint Petersburg, Buffalo and Jackson. To minimize the inconvenience of travelling for treatments, participants should opt to join a clinic closest to them."

Answered by AI

Am I eligible to participate in this study?

"This trial is seeking up to 220 individuals who have been intubated and are within the age range of 29 Weeks to 36 Weeks. Those interested in participating should apply as soon as possible."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
2024. "InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05960929.
~147 spots leftby Dec 2024
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