InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

Launched by ONY · Jul 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Infasurf®, which is delivered through a device called InfasurfAero™. This device is designed to help preterm newborns who have a condition called Respiratory Distress Syndrome (RDS), a common problem in babies born too early. The goal of the trial is to see if Infasurf® can be safely given without the need for a breathing tube, making it easier for the babies to receive this important treatment while they still get support for their breathing.

To be eligible for the study, babies must be between 29 and 36 weeks old at birth and weigh between 1,000 and 3,500 grams. They should also show signs of RDS, which means they might have difficulty breathing. Parents or legal guardians will need to provide consent for their participation. If a baby joins the trial, they can expect to receive either the Infasurf® treatment or a sham treatment (which does not contain the medication) to compare the effects. The trial is currently looking for participants, and it aims to provide more options for treating RDS effectively and safely.

Gender

ALL

Eligibility criteria

• 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