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Recruiting NCT05960929

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

Phase III Interventional Respiratory Distress Syndrome (Neonatal) Intubation Complication Death; Neonatal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Infasurf Aero™.
Who it may be relevant to
Registry conditions: Respiratory Distress Syndrome (Neonatal), Intubation Complication, Death; Neonatal. Basic parameters: 29 Weeks — 36 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial

Overview

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.

Detailed description

This single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support. Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf® (Intervention Arm) or respiratory air alone (Sham Control Arm) through the InfasurfAero™.

The objectives of this clinical study are to i) assess the effectiveness of a single dose of Infasurf administered through the InfasurfAero in preventing CPAP failure, and ii) assess the safety of Infasurf administered through the InfasurfAero.

Subjects will be enrolled at one of 10+ sites. 7 sites are currently recruited.

Interventions

  • Combination product Infasurf Aero™
    A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.

Primary outcome measures

  • CPAP failure and or death [Time frame: Within 1st week of age]
Secondary outcome measures (7)
  • Chronic lung disease and or death [Time frame: 36 weeks post menstrual age (PMA).]
  • Incidence of MV [Time frame: 36 weeks PMA]
  • Duration of MV [Time frame: 36 weeks PMA]
  • Incidence of intubation [Time frame: 36 weeks PMA]
  • Incidence of invasive surfactant replacement therapy [Time frame: 72 hours post birth]
  • Duration of non-invasive support [Time frame: 36 weeks PMA]
  • Duration of supplemental oxygen [Time frame: 36 weeks PMA]

Eligibility criteria

Inclusion criteria

Inclusion criteria include ALL of the following:

  • Written informed consent obtained by parent or legal representative prior to or after birth
  • Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
  • Birthweight ≥ 1,000 AND ≤ 3,500 grams
  • Age ≥ 1 hour AND ≤ 6 hours
  • 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
  • Require CPAP
  • Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
  • If subject is >346/7 weeks' gestation a chest radiograph is required

Exclusion criteria

Exclusion criteria are ANY of the following:

  • Surfactant administration prior to randomization
  • Mechanical ventilation prior to randomization
  • Major congenital anomaly (suspected or confirmed)
  • Abnormality of the airway (suspected or confirmed)
  • 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)
  • Apgar score < 3 at 5 minutes of age
  • Umbilical cord gas pH <7.0 or BD > 10
  • Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 10 centers
  • St. Josephs Hospital and Medical Center — Phoenix
  • Phoenix Children's — Phoenix
  • Sharp Mary Birch Hospital for Women & Newborns — San Diego
  • University of Florida -Jacksonville — Jacksonville
  • Kapi'olani Medical Center for Women & Children — Honolulu
  • Jersey Shore University Medical Center — Neptune City
  • Sisters of Charity Hospital — Buffalo
  • Western TN- Jackson-Madison County General Hospital — Jackson
  • … and 2 more centers

Identifiers

NCT: NCT05960929 · AERO-05 Protocol

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗