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Clinical Trials/EUCTR2015-003519-40-IE
EUCTR2015-003519-40-IEActive, not recruitingPhase 1

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

Windtree Therapeutics, Inc. (formerly named Discovery Laboratories, Inc)0 sites320 target enrollmentStarted: February 11, 2016Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
320
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •1. Signed ICF from legally authorized representative (consent may be obtained prenatally, where allowed)
  • •2. Gestational age:
  • •a. Part A: 28 0/7 to 32 6/7 completed weeks' gestation PMA
  • •b. Part B: 26 0/7 to 28 6/7 completed week´s gestation PMA
  • •3. Successful implementation of non-invasive support or ventilation (preferably bubble CPAP) within
  • •a. Part A: 90 minutes after birth
  • •b. Part B: 60 minutes after birth
  • •4. Spontaneous breathing
  • •5. Chest radiograph consistent with RDS (may be deferred if in the best medical interest of the subject)
  • •6. Respiratory support:
  • •a. Part A: 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 28 weeks PMA) to 0.4 that is clinically indicated for at least 30 minutes to maintain SpO2 of 90% to 95%.
  • •b. Part B: Within the first 12 hours after birth, requires an nCPAP of 5 to 7 cm H2O with an FiO2 of >0.21 to 0.4 that is clinically indicated for at least 20 minutes to maintain SpO2 of 90% to 95%.
  • •Transient (<10 minutes) FiO2 excursions outside this range do not reset the time requirement.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 320
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

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 (eg, 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 invasive MV at any time before enrollment into the study
  • •10. The administration (or plan for administration) of any the following:
  • •a) Another investigational agent or investigational medical device
  • •b) Any other surfactant agent
  • •c) 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

Investigators

Sponsor
Windtree Therapeutics, Inc. (formerly named Discovery Laboratories, Inc)

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