An international study at different study sites testing the safety and tolerability of a drug, lucinactant, which is to be inhaled as a means to treat breathing problems in babies born prematurely in the 26 to 28 weeks.

Phase 1

Active, not recruiting

• Conditions: Respiratory Distress Syndrome (RDS); MedDRA version: 19.1Level: LLTClassification code 10021735Term: Infant respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 19.1Level: LLTClassification code 10038690Term: Respiratory distress syndrome (neonatal)System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 19.1Level: PTClassification code 10028974Term: Neonatal respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-005624-26-PL
• Lead Sponsor: Windtree Therapeutics, Inc. (formerly Discovery Laboratories, Inc.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-25
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1.Signed ICF from legally authorized representative;
2.Gestational age 26 to 28 completed weeks PMA;
3.Successful implementation of controlled nCPAP 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 6 cm H2O to maintain SpO2 of 88% to 95% with an FiO2 of 0.25 to 0.50 that is clinically indicated for at least 30 minutes. Transient (<10 minutes) FiO2 excursions below 0.25 or above 0.50 do not reset the 30 minute requirement.

Are the trial subjects under 18? yes
Number of subjects for this age range: 64
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.Heart rate that cannot be stabilized above 100 beats per minutes within 5 minutes of birth;
2.Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface;
3.A 5 minute Apgar score < 5;
4.Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth;
5.Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH);
6.Known or suspected chromosomal abnormality or syndrome;
7.Premature rupture of membranes (PROM) > 2 weeks;
8.Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis;
9.Need for endotracheal intubation and/or mechanical ventilation;
10.Has been administered any the following:
a)Another investigational agent or investigational medical device,
b)Administration of any other surfactant agent,
c)Steroid treatment (exposure before birth is acceptable).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified