Infasurf Aero™ for Neonatal Respiratory Distress Syndrome

(Aero-05 Trial)

Recruiting at 11 trial locations

Overseen By Dan Swartz, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: ONY

Disqualifiers: Congenital anomaly, Airway abnormality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Single dose

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

Is Infasurf Aero™ safe for use in humans?

Research shows that Infasurf, a type of surfactant, has been studied for safety in treating respiratory distress syndrome in newborns. It has been compared to other surfactants and found to be generally safe for use in preterm infants. ^{1 2 3 4 5}

How is the drug Infasurf Aero™ different from other treatments for neonatal respiratory distress syndrome?

Infasurf Aero™ is unique because it is an aerosolized surfactant administered through a nasal device, which may offer a less invasive alternative compared to traditional methods that require direct instillation into the lungs. ^{1 2 4 6 7}

Who Is on the Research Team?

Scott Guthrie, MD

Principal Investigator

Vanderbilt Jackson-Madison, Jackson TN

Dinushan Kaluarachchi, MD

Principal Investigator

Unity Point Meriter, Madison WI

Jim Cummings, MD

Principal Investigator

Ony Biotech

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a newborn, less than 6 hours old.

My baby was born between 29 and 36 weeks of pregnancy.

I have been diagnosed with a severe lung condition needing treatment.

Exclusion Criteria

I have received surfactant treatment before being assigned to a study group.

Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

My breathing problems are not due to newborn lung disease but another condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer or sham treatment with respiratory air alone

Single dose

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of CPAP failure and other respiratory outcomes

36 weeks post menstrual age

What Are the Treatments Tested in This Trial?

Interventions

• InfasurfAero™

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer until completion.

Group II: Control Arm Placebo Group 1 Intervention

Low flow respiratory air alone through the InfasurfAero™ Nebulizer until completion.

Who Is Running the Clinical Trial?

ONY

Lead Sponsor

Trials

9

Recruited

1,400+

Avania

Industry Sponsor

Trials

59

Recruited

10,000+

Published Research Related to This Trial

In a study of 293 preterm infants with respiratory distress syndrome (RDS), treatment with 200 mg/kg of poractant alfa resulted in a faster reduction in the need for supplemental oxygen compared to beractant, indicating its efficacy in managing RDS.

Infants born at or below 32 weeks gestation who received 200 mg/kg of poractant alfa had significantly lower mortality rates (3%) compared to those treated with beractant (11%) or 100 mg/kg of poractant alfa, highlighting its potential safety and effectiveness in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, multicenter masked comparison trial of poractant alfa (Curosurf) versus beractant (Survanta) in the treatment of respiratory distress syndrome in preterm infants. Ramanathan, R., Rasmussen, MR., Gerstmann, DR., et al.[2022]

In a study of 871 premature infants, Infasurf significantly reduced the incidence of neonatal respiratory distress syndrome (RDS) by 62% and RDS-related deaths by 70% compared to Exosurf Neonatal, indicating its superior efficacy in preventing RDS.

While Infasurf was more effective, it was associated with a higher overall risk of total intraventricular hemorrhage (IVH), although severe IVH rates were similar between the two treatments, highlighting a safety consideration in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter randomized masked comparison trial of synthetic surfactant versus calf lung surfactant extract in the prevention of neonatal respiratory distress syndrome. Hudak, ML., Martin, DJ., Egan, EA., et al.[2019]

In a study of 203 premature infants with respiratory distress syndrome (RDS), Survanta surfactant showed a significantly greater improvement in respiratory function compared to Exosurf from 12 to 48 hours after treatment.

Both Survanta and Exosurf were effective in treating RDS, but Survanta provided a faster response, while Exosurf was associated with a higher rate of retinopathy of prematurity in older infants (28 to 32 weeks).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of exosurf and survanta surfactants on early clinical course of respiratory distress syndrome and complications of prematurity. Modanlou, HD., Beharry, K., Padilla, G., et al.[2018]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Trial of aerosolised surfactant for preterm infants with respiratory distress syndrome. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of Infasurf (calf lung surfactant extract) to Survanta (Beractant) in the treatment and prevention of respiratory distress syndrome. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized, multicenter masked comparison trial of poractant alfa (Curosurf) versus beractant (Survanta) in the treatment of respiratory distress syndrome in preterm infants. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A multicenter randomized masked comparison trial of synthetic surfactant versus calf lung surfactant extract in the prevention of neonatal respiratory distress syndrome. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A comparison of the outcomes of neonates treated with two different natural surfactants. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of Infasurf (calfactant) and Survanta (beractant) in the prevention and treatment of respiratory distress syndrome. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Comparative efficacy of exosurf and survanta surfactants on early clinical course of respiratory distress syndrome and complications of prematurity. [2018]