InfasurfAero™ for treating respiratory distress in preterm newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of Infasurf® delivered through the InfasurfAero™, a novel device designed for non-invasive administration without the need for intubation. The study involves a double-blind, randomized, sham-controlled design, where preterm newborns with respiratory distress syndrome (RDS) will receive either Infasurf or a sham treatment. The primary objectives are to assess the prevention of CPAP failure and the safety of the treatment. Participants will be recruited from multiple sites, with a focus on those who are stable on non-invasive respiratory support.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Inclusion criteria include ALL of the following:

1. Written informed consent obtained by parent or legal representative prior to or after birth
2. Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
3. Birthweight ≥ 1,000 AND ≤ 3,500 grams
4. Age ≥ 1 hour AND ≤ 6 hours
5. Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation
6. Require CPAP
7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
8. If subject is \>346/7 weeks' gestation a chest radiograph is required

Exclusion Criteria:

Exclusion criteria are ANY of the following:

1. Surfactant administration prior to randomization
2. Mechanical ventilation prior to randomization
3. Major congenital anomaly (suspected or confirmed)
4. Abnormality of the airway (suspected or confirmed)
5. Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)
6. Apgar score \< 3 at 5 minutes of age
7. Umbilical cord gas pH \<7.0 or BD \> 10
8. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

Where it's running

• St. Josephs Hospital and Medical Center
  Phoenix, Arizona, United States Recruiting
• Phoenix Children's
  Phoenix, Arizona, United States Recruiting
• Sharp Mary Birch Hospital for Women & Newborns
  San Diego, California, United States Recruiting
• University of Florida -Jacksonville
  Jacksonville, Florida, United States Recruiting
• Kapi'olani Medical Center for Women & Children
  Honolulu, Hawaii, United States Recruiting
• Jersey Shore University Medical Center
  Neptune City, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Corey Commaroto, RRT
• Email: ccommaroto@onybiotech.com
• Phone: 7163614659

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How Different Levels of CPAP Deliver Oxygen to Preterm Babies

  This study tests how much oxygen actually reaches preterm infants when they receive nasal CPAP at different air pressures.

  Recruiting University of Arkansas · Little Rock, Arkansas and 1 other locations · NCT07674953

• Reference intervals for newborn brain biomarkers

  Measure levels of brain-specific blood proteins (such as GFAP and Tau) in healthy full-term newborns during their first week of life to create normal reference ranges.

  Recruiting University College Cork · Cork · NCT07585149

• Surfactant delivery methods in preterm infants with RDS in Sweden

  This study tests different ways of giving surfactant to preterm babies with respiratory distress to see which method works best when care is routine.

  Recruiting Vastra Gotaland Region · Gothenburg · NCT07550218

• Video-guided vs direct laryngoscopy for less invasive surfactant delivery in extremely preterm infants

  This trial tests whether using video laryngoscopy helps give surfactant on the first try more often than direct laryngoscopy in extremely preterm babies needing surfactant.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT07426016

• Mindfulness and meditation lactation education for mothers of premature NICU infants

  This will test whether mindfulness and meditation training for mothers who are pumping for their premature NICU infants changes components of their breastmilk.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07351799

• Lung volume changes with synchronized noninvasive ventilator support in preterm infants

  This study will use a noninvasive imaging belt to see if synchronized ventilator inflations produce larger lung volumes than unsynchronized or backup inflations in very preterm infants on sNIPPV.

  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07237139

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.