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Trial to Assess the Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02636868
Recruitment Status : Unknown
Verified October 2017 by Windtree Therapeutics.
Recruitment status was:  Active, not recruiting
First Posted : December 22, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Windtree Therapeutics

Brief Summary:
The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for Resipiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Drug: Lucinactant delivered via investigational delivery device Drug: nCPAP Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Masked, Randomized, Controlled Study to Assess The Safety and Efficacy of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age With Respiratory Distress Syndrome
Actual Study Start Date : December 2015
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : August 2018


Arm Intervention/treatment
Experimental: Aerosolized lucinactant (low dose)
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Drug: Lucinactant delivered via investigational delivery device
Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)

Drug: nCPAP
Nasal CPAP

Experimental: Aerosolized lucinactant (high dose)
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Drug: Lucinactant delivered via investigational delivery device
Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)

Drug: nCPAP
Nasal CPAP

Active Comparator: nasal CPAP
nCPAP alone
Drug: nCPAP
Nasal CPAP




Primary Outcome Measures :
  1. Time to respiratory failure or death due to RDS [ Time Frame: Day 7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   26 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed ICF from legally authorized representative
  2. 26 0/7 to 32 6/7 completed weeks gestation PMA
  3. Successful implementation of non-invasive support or ventilation within 90 minutes after birth
  4. Spontaneous breathing
  5. Chest radiograph consistent with RDS
  6. Within the first 20 hours after birth requires an nCPAP of 5 to 7 cm H2O with an FiO2 of ≥ 0.25 (>0.21 for neonates 26-28 weeks PMA) to 0.40 that is clinically indicated for at least 30 minutes to maintain SpO2 of 90% to 95%. Transient (<10 minutes) FiO2 excursions outside this range do not reset the 30-minute requirement.

Exclusion Criteria:

  1. A heart rate that cannot be stabilized above 100 beats per minute (bpm) within 5 minutes of birth
  2. Recurrent episodes of apnea requiring positive pressure ventilation (PPV) administered manually or mechanically through any patient interface
  3. A 5 minute Apgar score < 5
  4. Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP, diagnosed antenatally or immediately after birth
  5. Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function (e.g. congenital heart disease, hydrops fetalis or congenital infection)
  6. A known or suspected chromosomal abnormality or syndrome
  7. Premature rupture of membranes (PROM) > 3 weeks
  8. Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
  9. A need for intubation and/or mechanical ventilation at any time before enrollment into the study
  10. The administration (or plan for administration) of any the following:

    • Another investigational agent or investigational medical device
    • Any other surfactant agent
    • Systemic corticosteroids (other than antenatal steroids already received)
  11. Presence of air leak (pneumothorax, pneumomediastinum, pneumopericardium, subcutaneous emphysema, or definite evidence of pulmonary interstitial emphysema [PIE]) on the baseline chest radiograph

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636868


Locations
Show Show 44 study locations
Sponsors and Collaborators
Windtree Therapeutics
Investigators
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Study Director: Steven Simonson, MD Windtree Therapeutics
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Responsible Party: Windtree Therapeutics
ClinicalTrials.gov Identifier: NCT02636868    
Other Study ID Numbers: 03-CL-1202
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases