An international study at different sites testing the safety and effectiveness of an investigational drug called lucinactant, which is to be inhaled to treat breathing problems in babies born prematurely at a gestational age of 26 to 32 weeks.

A Multinational, Multicenter, Masked, Randomized, Parallel Group, Controlled Study to Assess the Safety and Efficacy of Lucinactant for Inhalation versus nCPAP alone in Preterm Neonates 26 to 32 Weeks Gestational Age with Respiratory Distress Syndrome.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000106-32-PL

Enrollment

130

Registered

2019-03-26

Start date

2019-06-26

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome (RDS) MedDRA version: 21.1 Level: LLT Classification code 10021735 Term: Infant respiratory distress syndrome System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1 Level: LLT Classification code 10038690 Term: Respiratory distress syndrome (neonatal) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1 Level: PT Classification code 10028974 Term: Neonatal respiratory dist

Interventions

Product Name: Lyophilized lucinactant Product Code: R07AA-30 Pharmaceutical Form: Nebuliser suspension INN or Proposed INN: dipalmitoylphosphatidylcholine CAS Number: 63-89-8 Current Sponsor code: 401

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed ICF from legally authorized representative. It is recommended that consent is obtained antenatally (where permitted). 2. Gestational age: 26 + 0/7 to 32 + 6/7 weeks PMA 3. Successful implementation of non-invasive ventilation within 30 minutes after birth. 4. Spontaneous breathing. 5. Investigator determination of RDS. A chest x-ray should be obtained before treatment to confirm the diagnosis. 6. Within the first 6 hours after birth, requires an nCPAP of 5 to 7 cm H2O that is clinically indicated for at least 15 minutes with an FiO2 > 0.25 to = 0.35 to maintain SpO2 of 90% to 95%. Transient (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 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 mechanical ventilation 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) 11. Presence of air leak (pneumothorax, pneumomediastinum, pneumopericardium, subcutaneous emphysema, or definite evidence of pulmonary interstitial emphysema [PIE]) on the baseline chest radiograph, or diagnosed via ultrasound or illumination.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and efficacy of lucinactant for inhalation delivered by the next generation ADS device in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory failure due to RDS in the first 72 hours and through 28 days of life, oxygen saturation and use of supplemental oxygen, all-cause mortality through 28 days of life, the incidence of bronchopulmonary dysplasia (BPD) at 36 weeks PMA, and the duration of mechanical ventilation. In addition, this study will evaluate the device performance and the ability to administer up to 3 lucinactant for inhalation repeat treatments.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint for this study is the number of subjects with respiratory failure due to RDS or death within the first 28 days of life. Respiratory failure due to RDS is defined as intubation (including intratracheal catheter placement) for MV and/or surfactant administration. ;Timepoint(s) of evaluation of this end point: within the first 72 hours of life or after 72 hours of life and within 28 days of life.	—

Measure

Time frame

Main Objective: To evaluate the safety and efficacy of lucinactant for inhalation delivered by the next generation ADS device in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory failure due to RDS in the first 72 hours and through 28 days of life, oxygen saturation and use of supplemental oxygen, all-cause mortality through 28 days of life, the incidence of bronchopulmonary dysplasia (BPD) at 36 weeks PMA, and the duration of mechanical ventilation. In addition, this study will evaluate the device performance and the ability to administer up to 3 lucinactant for inhalation repeat treatments.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint for this study is the number of subjects with respiratory failure due to RDS or death within the first 28 days of life. Respiratory failure due to RDS is defined as intubation (including intratracheal catheter placement) for MV and/or surfactant administration. ;Timepoint(s) of evaluation of this end point: within the first 72 hours of life or after 72 hours of life and within 28 days of life.

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Secondary

Measure	Time frame
Secondary end point(s): The key secondary endpoints of this study include the evaluation of the following: • Respiratory failure through 72 hours and 28 days of life • Time to respiratory failure through 72 hours and 28 days of life • BPD and survival without BPD at 36 weeks PMA • Severity of BPD at 36 weeks PMA • Oxygen saturation and use of supplemental oxygen • All cause mortality through 28 days of life and 36 weeks PMA Other secondary endpoints of this study include the evaluation of the following: • Common complications of prematurity through 36 weeks PMA • Duration of MV and oxygen requirement through 36 weeks PMA • Changes in fraction of inspired oxygen (FiO2), partial pressure of carbon dioxide (PCO2) and oxygen (O2) saturation, as determined by pulse oximetry (SpO2) over the first 72 hours of life, and over the first 7 days of life for FiO2. • Number and duration of re-hospitalizations and reason for re-hospitalization through 12 months corrected age. • Respiratory medications through 12 months corrected age. ;Timepoint(s) of evaluation of this end point: the first 72 hours of life, the first 7 days of life and through 36 weeks PMA	—

Measure

Time frame

Secondary end point(s): The key secondary endpoints of this study include the evaluation of the following: • Respiratory failure through 72 hours and 28 days of life • Time to respiratory failure through 72 hours and 28 days of life • BPD and survival without BPD at 36 weeks PMA • Severity of BPD at 36 weeks PMA • Oxygen saturation and use of supplemental oxygen • All cause mortality through 28 days of life and 36 weeks PMA Other secondary endpoints of this study include the evaluation of the following: • Common complications of prematurity through 36 weeks PMA • Duration of MV and oxygen requirement through 36 weeks PMA • Changes in fraction of inspired oxygen (FiO2), partial pressure of carbon dioxide (PCO2) and oxygen (O2) saturation, as determined by pulse oximetry (SpO2) over the first 72 hours of life, and over the first 7 days of life for FiO2. • Number and duration of re-hospitalizations and reason for re-hospitalization through 12 months corrected age. • Respiratory medications through 12 months corrected age. ;Timepoint(s) of evaluation of this end point: the first 72 hours of life, the first 7 days of life and through 36 weeks PMA

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Countries

Chile, China, Poland, United States

Contacts

Public ContactClinical Operations

Clinical Consulting Sp. z o.o.

tadeusz.baron@clinicalconsulting.pl+48322272005

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026