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Completed

NCT Number: NCT03969992

A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact

The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.

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Key information

Conditions

Respiratory Distress Syndrome in Premature Infant Female Urogenital Diseases and Pregnancy Complications Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases

Age range

26 week–31 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IWK Hospital, Halifax, Nova Scotia, Canada

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About this study

Part I Primary Objective To determine an optimal dose of AeroFact administered by nasal continuous positive airway pressure (nCPAP) versus stand of care in reducing the rate of intubation/cannulation and bolus surfactant instillation in the first 7 days after birth.

Part II Primary Objective To evaluate pulmonary outcomes and respiratory utilization at 3, 6, 9, and 12 months post-menstrual age (PMA)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)
  • 26 0/7 to 30 6/7 weeks of gestational age
  • Weight <2.0 Kg
  • Respiratory Severity Score (RSS) 1.4-2.0

Exclusion criteria

  • Apgar score less than or equal to 5 at five minutes after birth
  • Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room
  • Premature rupture of membranes (PROM) > 14 days
  • Need for intubation and/or mechanical ventilation prior to enrollment
  • Active pneumothorax requiring chest tube
  • Significant congenital anomaly, chromosomal abnormality
  • Concomitant treatments with inhaled nitric oxide

Treatment and study plan

AeroFact

Drug

Aerosolized SF-RI 1

Other names: SF-RI 1

nCPAP

Other

nCPAP (nasal continuous positive airway pressure) alone

Primary outcomes

  1. Intubation/Cannulation and Instilled Surfactant

    Time frame: First 7 days of life

    Number of patients who require intubation/cannulation with bolus surfactant instillation

Secondary outcomes

  1. Time to First Intubation/Cannulation and Bolus Surfactant Instillation

    Time frame: First 7 days of life

    Time from randomization to intubation/cannulation and bolus surfactant instillation in the first 7 days of life

  2. Proportion of Infants Who Received Multiple Doses of Bolus Surfactant

    Time frame: First 7 days of life

  3. Number of Days on Invasive Mechanical Ventilation

    Time frame: Assessed daily from birth to 40 weeks post-menstrual age or discharge

    Total number of days each participant required support with invasive mechanical ventilation

  4. Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post-menstrual Age (PMA)

    Time frame: Birth to 36 weeks post-menstrual age

    Total number of patients per treatment group who were alive and did not experience BPD at 36 weeks PMA

  5. Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 40 Weeks Post-menstrual Age (PMA)

    Time frame: Birth to 40 weeks post-menstrual age

    Total number of patients per treatment group who were alive and did not experience BPD at 40 weeks PMA

Sponsors and collaborators

Lead sponsor

Aerogen Pharma Limited

Industry

Registry information

Official study title

A Partially Blinded, Randomized, Controlled, Parallel-Group, Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact in Preterm Infants at Risk of Worsening Respiratory Distress Syndrome

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
May 31, 2019
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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