Respiratory Distress Syndrome
Conditions
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to neonates receiving nCPAP alone.
Interventions
Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
DEVICEnCPAP alone
nCPAP therapy
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Windtree Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Sequential escalating dosing groups, each group contained an active and control arm of equal size.
Eligibility
Sex/Gender
ALL
Age
29 Weeks to 34 Weeks
Healthy volunteers
No
Inclusion criteria
* Informed consent from a legally authorized representative * Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA) * Successful implementation of controlled nCPAP within 90 minutes after birth * Spontaneous breathing * Chest radiograph consistent with RDS * Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 30 minutes within the first 21 hours after birth
Exclusion criteria
* Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth * 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 * A 5 minute Apgar score \< 5 * Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth * Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH) * Known or suspected chromosomal abnormality or syndrome * Prolong rupture of membranes (PROM) \> 2 weeks * Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis * Need for endotracheal intubation and mechanical ventilation * Has been administered: another investigational agent or exposure to an investigational medical device, any other surfactant agent, steroid treatment after birth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri-Dosing Events | Within 48 Hours after Initiation of Study Treatment | Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone |
| All Cause Mortality | Within 36 Weeks PMA | — |
| Oxygen Saturation Levels | Within 3 Hours of Randomization | Oxygen saturation as determined by pulse oximetry |
| Serum Electrolytes | 24 Hours Post Randomization | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PCO2 | Within 3 Hours of Randomization | Arterial carbon dioxide |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aerolized Lucinactant (25 mg/kg) 25 mg TPL/kg of lucinactant for inhalation with nCPAP | 8 |
| Aerosolized Lucinactant (50 mg/kg) 50 mg TPL/kg of lucinactant for inhalation with nCPAP | 8 |
| Aerosolized Lucinactant (75 mg/kg) 75 mg TPL/kg of lucinactant for inhalation with nCPAP | 8 |
| Aerosolized Lucinactant (100 mg/kg) 100 mg TPL/kg of lucinactant for Inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met | 8 |
| Aerosolized Lucinactant (150 mg/kg) 150 mg TPL/kg of lucinactant for Inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met | 8 |
| nCPAP Alone nCPAP therapy alone | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Aerolized Lucinactant (25 mg/kg) | Aerosolized Lucinactant (50 mg/kg) | Aerosolized Lucinactant (75 mg/kg) | Aerosolized Lucinactant (100 mg/kg) | Aerosolized Lucinactant (150 mg/kg) | nCPAP Alone | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 40 Participants | 80 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 2 Participants | 2 Participants | 2 Participants | 11 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 29 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Gestational Age | 30.5 weeks STANDARD_DEVIATION 0.81 | 31.8 weeks STANDARD_DEVIATION 1.5 | 33.3 weeks STANDARD_DEVIATION 2.11 | 31.7 weeks STANDARD_DEVIATION 2.1 | 32.3 weeks STANDARD_DEVIATION 1.95 | 31.5 weeks STANDARD_DEVIATION 1.56 | 31.7 weeks STANDARD_DEVIATION 1.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 4 Participants | 5 Participants | 6 Participants | 30 Participants | 54 Participants |
| Region of Enrollment United States | 8 participants | 8 participants | 8 participants | 8 participants | 8 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 4 Participants | 3 Participants | 6 Participants | 21 Participants | 42 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 4 Participants | 5 Participants | 2 Participants | 19 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 8 | 8 / 8 | 8 / 8 | 7 / 8 | 8 / 8 | 37 / 40 |
| serious Total, serious adverse events | 2 / 8 | 3 / 8 | 2 / 8 | 3 / 8 | 3 / 8 | 7 / 40 |
Outcome results
Primary
All Cause Mortality
Time frame: Within 36 Weeks PMA
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aerolized Lucinactant (25 mg/kg) | All Cause Mortality | 0 participants |
| Aerosolized Lucinactant (50 mg/kg) | All Cause Mortality | 0 participants |
| Aerosolized Lucinactant (75 mg/kg) | All Cause Mortality | 0 participants |
| Aerosolized Lucinactant (100 mg/kg) | All Cause Mortality | 0 participants |
| Aerosolized Lucinactant (150 mg/kg) | All Cause Mortality | 1 participants |
| nCPAP Alone | All Cause Mortality | 1 participants |
Primary
Oxygen Saturation Levels
Oxygen saturation as determined by pulse oximetry
Time frame: Within 3 Hours of Randomization
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerolized Lucinactant (25 mg/kg) | Oxygen Saturation Levels | At Randomization | 94.0 percentage of oxygen saturation | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | Oxygen Saturation Levels | 60 Minutes Post Randomization/Treatment | 92.0 percentage of oxygen saturation | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | Oxygen Saturation Levels | 2.75 Hours Post Randomization/Treatment | 98.0 percentage of oxygen saturation | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | Oxygen Saturation Levels | 2.25 Hours Post Randomization/Treatment | 90.5 percentage of oxygen saturation | Standard Deviation 2.12 |
| Aerolized Lucinactant (25 mg/kg) | Oxygen Saturation Levels | 30 Minutes Post Randomization/Treatment | 93.5 percentage of oxygen saturation | Standard Deviation 2.12 |
| Aerolized Lucinactant (25 mg/kg) | Oxygen Saturation Levels | 1.5 Hours Post Randomization/Treatment | 95.0 percentage of oxygen saturation | Standard Deviation 4.24 |
| Aerolized Lucinactant (25 mg/kg) | Oxygen Saturation Levels | 1.25 Hours Post Randomization/Treatment | 94.0 percentage of oxygen saturation | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | Oxygen Saturation Levels | 2.50 Hours Post Randomization | 91.0 percentage of oxygen saturation | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | Oxygen Saturation Levels | 2.00 Hours Post Radomization/Treatment | 97.0 percentage of oxygen saturation | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | Oxygen Saturation Levels | 15 Minutes Post Radomization/Treatment | 94.0 percentage of oxygen saturation | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | Oxygen Saturation Levels | 45 Minutes Post Randomization/Treatment | 94.5 percentage of oxygen saturation | Standard Deviation 0.71 |
| Aerolized Lucinactant (25 mg/kg) | Oxygen Saturation Levels | At Initiation of Treatment | 93.0 percentage of oxygen saturation | Standard Deviation 4 |
| Aerolized Lucinactant (25 mg/kg) | Oxygen Saturation Levels | 1.75 Hours Post Randomization/Treatment | 92.3 percentage of oxygen saturation | Standard Deviation 8.33 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | 45 Minutes Post Randomization/Treatment | 91.3 percentage of oxygen saturation | Standard Deviation 3.88 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | 2.75 Hours Post Randomization/Treatment | 94.5 percentage of oxygen saturation | Standard Deviation 1.29 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | 1.5 Hours Post Randomization/Treatment | 93.7 percentage of oxygen saturation | Standard Deviation 3.27 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | 60 Minutes Post Randomization/Treatment | 93.7 percentage of oxygen saturation | Standard Deviation 2.07 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | 1.25 Hours Post Randomization/Treatment | 93.2 percentage of oxygen saturation | Standard Deviation 4.71 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | At Initiation of Treatment | 93.3 percentage of oxygen saturation | Standard Deviation 1.37 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | At Randomization | 91.3 percentage of oxygen saturation | Standard Deviation 2.73 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | 2.50 Hours Post Randomization | 93.3 percentage of oxygen saturation | Standard Deviation 1.37 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | 15 Minutes Post Radomization/Treatment | 92.7 percentage of oxygen saturation | Standard Deviation 4.68 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | 2.25 Hours Post Randomization/Treatment | 92.3 percentage of oxygen saturation | Standard Deviation 2.42 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | 30 Minutes Post Randomization/Treatment | 92.3 percentage of oxygen saturation | Standard Deviation 2.25 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | 3.00 Hours Post Randomization | 93.5 percentage of oxygen saturation | Standard Deviation 5.45 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | 2.00 Hours Post Radomization/Treatment | 90.2 percentage of oxygen saturation | Standard Deviation 6.24 |
| Aerosolized Lucinactant (50 mg/kg) | Oxygen Saturation Levels | 1.75 Hours Post Randomization/Treatment | 93.3 percentage of oxygen saturation | Standard Deviation 4.13 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | 2.25 Hours Post Randomization/Treatment | 94.5 percentage of oxygen saturation | Standard Deviation 3.38 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | At Randomization | 96.4 percentage of oxygen saturation | Standard Deviation 2.2 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | At Initiation of Treatment | 93.4 percentage of oxygen saturation | Standard Deviation 4.24 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | 15 Minutes Post Radomization/Treatment | 94.8 percentage of oxygen saturation | Standard Deviation 5.15 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | 30 Minutes Post Randomization/Treatment | 92.5 percentage of oxygen saturation | Standard Deviation 5.95 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | 45 Minutes Post Randomization/Treatment | 94.0 percentage of oxygen saturation | Standard Deviation 4.72 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | 60 Minutes Post Randomization/Treatment | 96.1 percentage of oxygen saturation | Standard Deviation 2.47 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | 1.25 Hours Post Randomization/Treatment | 95.6 percentage of oxygen saturation | Standard Deviation 2.33 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | 1.5 Hours Post Randomization/Treatment | 94.9 percentage of oxygen saturation | Standard Deviation 3.52 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | 1.75 Hours Post Randomization/Treatment | 95.4 percentage of oxygen saturation | Standard Deviation 2.45 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | 2.00 Hours Post Radomization/Treatment | 95.0 percentage of oxygen saturation | Standard Deviation 2.78 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | 2.50 Hours Post Randomization | 95.0 percentage of oxygen saturation | Standard Deviation 2.62 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | 2.75 Hours Post Randomization/Treatment | 94.1 percentage of oxygen saturation | Standard Deviation 3.64 |
| Aerosolized Lucinactant (75 mg/kg) | Oxygen Saturation Levels | 3.00 Hours Post Randomization | 95.0 percentage of oxygen saturation | Standard Deviation 2.45 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | 1.75 Hours Post Randomization/Treatment | 94.6 percentage of oxygen saturation | Standard Deviation 4.72 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | 2.00 Hours Post Radomization/Treatment | 93.9 percentage of oxygen saturation | Standard Deviation 3.87 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | 1.25 Hours Post Randomization/Treatment | 94.0 percentage of oxygen saturation | Standard Deviation 3.32 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | 45 Minutes Post Randomization/Treatment | 93.8 percentage of oxygen saturation | Standard Deviation 3.11 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | 1.5 Hours Post Randomization/Treatment | 93.1 percentage of oxygen saturation | Standard Deviation 6.34 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | 2.75 Hours Post Randomization/Treatment | 94.7 percentage of oxygen saturation | Standard Deviation 2.63 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | 15 Minutes Post Radomization/Treatment | 94.8 percentage of oxygen saturation | Standard Deviation 3.62 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | 2.25 Hours Post Randomization/Treatment | 94.9 percentage of oxygen saturation | Standard Deviation 3.18 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | 60 Minutes Post Randomization/Treatment | 93.9 percentage of oxygen saturation | Standard Deviation 3.72 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | At Randomization | 93.9 percentage of oxygen saturation | Standard Deviation 3.87 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | 30 Minutes Post Randomization/Treatment | 93.3 percentage of oxygen saturation | Standard Deviation 4.83 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | At Initiation of Treatment | 94.0 percentage of oxygen saturation | Standard Deviation 3.82 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | 3.00 Hours Post Randomization | 95.4 percentage of oxygen saturation | Standard Deviation 3.46 |
| Aerosolized Lucinactant (100 mg/kg) | Oxygen Saturation Levels | 2.50 Hours Post Randomization | 94.0 percentage of oxygen saturation | Standard Deviation 3.61 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | 45 Minutes Post Randomization/Treatment | 93.0 percentage of oxygen saturation | Standard Deviation 2.27 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | 1.75 Hours Post Randomization/Treatment | 93.4 percentage of oxygen saturation | Standard Deviation 5.42 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | At Randomization | 92.5 percentage of oxygen saturation | Standard Deviation 3.85 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | 3.00 Hours Post Randomization | 94.9 percentage of oxygen saturation | Standard Deviation 3.36 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | 1.5 Hours Post Randomization/Treatment | 88.1 percentage of oxygen saturation | Standard Deviation 16.98 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | 60 Minutes Post Randomization/Treatment | 91.9 percentage of oxygen saturation | Standard Deviation 3 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | 2.75 Hours Post Randomization/Treatment | 92.8 percentage of oxygen saturation | Standard Deviation 4.13 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | 1.25 Hours Post Randomization/Treatment | 92.0 percentage of oxygen saturation | Standard Deviation 5.26 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | 30 Minutes Post Randomization/Treatment | 91.4 percentage of oxygen saturation | Standard Deviation 3.89 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | 2.50 Hours Post Randomization | 93.6 percentage of oxygen saturation | Standard Deviation 4.31 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | 2.00 Hours Post Radomization/Treatment | 93.4 percentage of oxygen saturation | Standard Deviation 3.58 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | 15 Minutes Post Radomization/Treatment | 92.0 percentage of oxygen saturation | Standard Deviation 4.66 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | 2.25 Hours Post Randomization/Treatment | 92.8 percentage of oxygen saturation | Standard Deviation 4.46 |
| Aerosolized Lucinactant (150 mg/kg) | Oxygen Saturation Levels | At Initiation of Treatment | 93.1 percentage of oxygen saturation | Standard Deviation 1.25 |
| nCPAP Alone | Oxygen Saturation Levels | 1.25 Hours Post Randomization/Treatment | 93.9 percentage of oxygen saturation | Standard Deviation 3.05 |
| nCPAP Alone | Oxygen Saturation Levels | 2.75 Hours Post Randomization/Treatment | 93.5 percentage of oxygen saturation | Standard Deviation 2.99 |
| nCPAP Alone | Oxygen Saturation Levels | 1.5 Hours Post Randomization/Treatment | 93.4 percentage of oxygen saturation | Standard Deviation 2.83 |
| nCPAP Alone | Oxygen Saturation Levels | 30 Minutes Post Randomization/Treatment | 93.6 percentage of oxygen saturation | Standard Deviation 3.33 |
| nCPAP Alone | Oxygen Saturation Levels | 1.75 Hours Post Randomization/Treatment | 93.9 percentage of oxygen saturation | Standard Deviation 2.61 |
| nCPAP Alone | Oxygen Saturation Levels | 3.00 Hours Post Randomization | 93.9 percentage of oxygen saturation | Standard Deviation 2.52 |
| nCPAP Alone | Oxygen Saturation Levels | 2.00 Hours Post Radomization/Treatment | 93.5 percentage of oxygen saturation | Standard Deviation 2.33 |
| nCPAP Alone | Oxygen Saturation Levels | 15 Minutes Post Radomization/Treatment | 93.3 percentage of oxygen saturation | Standard Deviation 3.39 |
| nCPAP Alone | Oxygen Saturation Levels | 2.25 Hours Post Randomization/Treatment | 93.4 percentage of oxygen saturation | Standard Deviation 2.63 |
| nCPAP Alone | Oxygen Saturation Levels | 2.50 Hours Post Randomization | 93.4 percentage of oxygen saturation | Standard Deviation 3.19 |
| nCPAP Alone | Oxygen Saturation Levels | At Randomization | 93.3 percentage of oxygen saturation | Standard Deviation 2.66 |
| nCPAP Alone | Oxygen Saturation Levels | 60 Minutes Post Randomization/Treatment | 93.5 percentage of oxygen saturation | Standard Deviation 3.68 |
| nCPAP Alone | Oxygen Saturation Levels | 45 Minutes Post Randomization/Treatment | 93.7 percentage of oxygen saturation | Standard Deviation 3.04 |
Primary
Peri-Dosing Events
Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone
Time frame: Within 48 Hours after Initiation of Study Treatment
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aerolized Lucinactant (25 mg/kg) | Peri-Dosing Events | Bradycardia | 0 participants |
| Aerolized Lucinactant (25 mg/kg) | Peri-Dosing Events | Vomiting | 0 participants |
| Aerolized Lucinactant (25 mg/kg) | Peri-Dosing Events | Desaturation | 2 participants |
| Aerosolized Lucinactant (50 mg/kg) | Peri-Dosing Events | Desaturation | 0 participants |
| Aerosolized Lucinactant (50 mg/kg) | Peri-Dosing Events | Bradycardia | 0 participants |
| Aerosolized Lucinactant (50 mg/kg) | Peri-Dosing Events | Vomiting | 0 participants |
| Aerosolized Lucinactant (75 mg/kg) | Peri-Dosing Events | Desaturation | 1 participants |
| Aerosolized Lucinactant (75 mg/kg) | Peri-Dosing Events | Bradycardia | 0 participants |
| Aerosolized Lucinactant (75 mg/kg) | Peri-Dosing Events | Vomiting | 1 participants |
| Aerosolized Lucinactant (100 mg/kg) | Peri-Dosing Events | Bradycardia | 1 participants |
| Aerosolized Lucinactant (100 mg/kg) | Peri-Dosing Events | Vomiting | 1 participants |
| Aerosolized Lucinactant (100 mg/kg) | Peri-Dosing Events | Desaturation | 2 participants |
| Aerosolized Lucinactant (150 mg/kg) | Peri-Dosing Events | Desaturation | 0 participants |
| Aerosolized Lucinactant (150 mg/kg) | Peri-Dosing Events | Bradycardia | 0 participants |
| Aerosolized Lucinactant (150 mg/kg) | Peri-Dosing Events | Vomiting | 0 participants |
Primary
Serum Electrolytes
Time frame: 24 Hours Post Randomization
Population: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerolized Lucinactant (25 mg/kg) | Serum Electrolytes | Sodium | 140 mEq/L | Standard Deviation 3.7 |
| Aerolized Lucinactant (25 mg/kg) | Serum Electrolytes | Chloride | 108 mEq/L | Standard Deviation 3 |
| Aerolized Lucinactant (25 mg/kg) | Serum Electrolytes | Total Carbon Dioxide | 20.8 mEq/L | Standard Deviation 1.83 |
| Aerolized Lucinactant (25 mg/kg) | Serum Electrolytes | Potassium | 3.86 mEq/L | Standard Deviation 0.262 |
| Aerosolized Lucinactant (50 mg/kg) | Serum Electrolytes | Sodium | 137 mEq/L | Standard Deviation 4 |
| Aerosolized Lucinactant (50 mg/kg) | Serum Electrolytes | Potassium | 4.66 mEq/L | Standard Deviation 1.235 |
| Aerosolized Lucinactant (50 mg/kg) | Serum Electrolytes | Chloride | 107 mEq/L | Standard Deviation 4.2 |
| Aerosolized Lucinactant (50 mg/kg) | Serum Electrolytes | Total Carbon Dioxide | 21.3 mEq/L | Standard Deviation 2.12 |
| Aerosolized Lucinactant (75 mg/kg) | Serum Electrolytes | Potassium | 3.86 mEq/L | Standard Deviation 0.453 |
| Aerosolized Lucinactant (75 mg/kg) | Serum Electrolytes | Sodium | 139 mEq/L | Standard Deviation 4.2 |
| Aerosolized Lucinactant (75 mg/kg) | Serum Electrolytes | Total Carbon Dioxide | 22.0 mEq/L | Standard Deviation 1.6 |
| Aerosolized Lucinactant (75 mg/kg) | Serum Electrolytes | Chloride | 107 mEq/L | Standard Deviation 6.6 |
| Aerosolized Lucinactant (100 mg/kg) | Serum Electrolytes | Sodium | 140 mEq/L | Standard Deviation 4.9 |
| Aerosolized Lucinactant (100 mg/kg) | Serum Electrolytes | Chloride | 107 mEq/L | Standard Deviation 6.3 |
| Aerosolized Lucinactant (100 mg/kg) | Serum Electrolytes | Potassium | 4.46 mEq/L | Standard Deviation 1.029 |
| Aerosolized Lucinactant (100 mg/kg) | Serum Electrolytes | Total Carbon Dioxide | 24.5 mEq/L | Standard Deviation 7.5 |
| Aerosolized Lucinactant (150 mg/kg) | Serum Electrolytes | Total Carbon Dioxide | 21.9 mEq/L | Standard Deviation 1.89 |
| Aerosolized Lucinactant (150 mg/kg) | Serum Electrolytes | Chloride | 105 mEq/L | Standard Deviation 4.5 |
| Aerosolized Lucinactant (150 mg/kg) | Serum Electrolytes | Sodium | 137 mEq/L | Standard Deviation 4.3 |
| Aerosolized Lucinactant (150 mg/kg) | Serum Electrolytes | Potassium | 4.09 mEq/L | Standard Deviation 0.993 |
| nCPAP Alone | Serum Electrolytes | Chloride | 108 mEq/L | Standard Deviation 3.5 |
| nCPAP Alone | Serum Electrolytes | Potassium | 4.47 mEq/L | Standard Deviation 1.082 |
| nCPAP Alone | Serum Electrolytes | Total Carbon Dioxide | 21.7 mEq/L | Standard Deviation 3.12 |
| nCPAP Alone | Serum Electrolytes | Sodium | 139 mEq/L | Standard Deviation 3.3 |
Secondary
PCO2
Arterial carbon dioxide
Time frame: Within 3 Hours of Randomization
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerolized Lucinactant (25 mg/kg) | PCO2 | 2.25 Hours Post Randomization/Treatment | 33.5 percentage of arterial carbon dioxide | Standard Deviation 10.61 |
| Aerolized Lucinactant (25 mg/kg) | PCO2 | 2.50 Hours Post Randomization/Treatment | 36.0 percentage of arterial carbon dioxide | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | PCO2 | 30 Minutes Post Randomization/Treatment | 38.0 percentage of arterial carbon dioxide | Standard Deviation 12.73 |
| Aerolized Lucinactant (25 mg/kg) | PCO2 | 60 Minutes Post Randomization/Treatment | 39.0 percentage of arterial carbon dioxide | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | PCO2 | At Randomization | 58.0 percentage of arterial carbon dioxide | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | PCO2 | 2.00 Hours Post Randomization/Treatment | 30.0 percentage of arterial carbon dioxide | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | PCO2 | 2.75 Hours Post Randomization/Treatment | 37.0 percentage of arterial carbon dioxide | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | PCO2 | 1.75 Hours Post Randomization/Treatment | 48.0 percentage of arterial carbon dioxide | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | PCO2 | 45 Minutes Post Randomization/Treatment | 32.0 percentage of arterial carbon dioxide | Standard Deviation 0 |
| Aerolized Lucinactant (25 mg/kg) | PCO2 | At Initiation of Treatment | 29.0 percentage of arterial carbon dioxide | Standard Deviation 1.73 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | 2.00 Hours Post Randomization/Treatment | 46.6 percentage of arterial carbon dioxide | Standard Deviation 7.72 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | 30 Minutes Post Randomization/Treatment | 53.1 percentage of arterial carbon dioxide | Standard Deviation 8.37 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | 1.75 Hours Post Randomization/Treatment | 45.7 percentage of arterial carbon dioxide | Standard Deviation 8.44 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | 2.75 Hours Post Randomization/Treatment | 44.2 percentage of arterial carbon dioxide | Standard Deviation 5.02 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | 45 Minutes Post Randomization/Treatment | 50.3 percentage of arterial carbon dioxide | Standard Deviation 7.94 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | 1.50 Hours Post Randomization/Treatment | 47.5 percentage of arterial carbon dioxide | Standard Deviation 9.62 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | 1.25 Hours Post Randomization/Treatment | 50.5 percentage of arterial carbon dioxide | Standard Deviation 9.72 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | 60 Minutes Post Randomization/Treatment | 49.7 percentage of arterial carbon dioxide | Standard Deviation 9.62 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | At Initiation of Treatment | 53.0 percentage of arterial carbon dioxide | Standard Deviation 9.34 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | At Randomization | 54.3 percentage of arterial carbon dioxide | Standard Deviation 8.96 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | 2.50 Hours Post Randomization/Treatment | 45.6 percentage of arterial carbon dioxide | Standard Deviation 7.2 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | 15 Minutes Post Randomization/Treatment | 50.1 percentage of arterial carbon dioxide | Standard Deviation 10.42 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | 3.00 Hours Post Randomization/Treatment | 45.6 percentage of arterial carbon dioxide | Standard Deviation 6.54 |
| Aerosolized Lucinactant (50 mg/kg) | PCO2 | 2.25 Hours Post Randomization/Treatment | 45.4 percentage of arterial carbon dioxide | Standard Deviation 8.49 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | 30 Minutes Post Randomization/Treatment | 48.4 percentage of arterial carbon dioxide | Standard Deviation 12.13 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | At Randomization | 47.1 percentage of arterial carbon dioxide | Standard Deviation 8.32 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | At Initiation of Treatment | 52.3 percentage of arterial carbon dioxide | Standard Deviation 11.34 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | 15 Minutes Post Randomization/Treatment | 53.1 percentage of arterial carbon dioxide | Standard Deviation 16.03 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | 45 Minutes Post Randomization/Treatment | 46.2 percentage of arterial carbon dioxide | Standard Deviation 9.41 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | 60 Minutes Post Randomization/Treatment | 47.3 percentage of arterial carbon dioxide | Standard Deviation 11.53 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | 1.25 Hours Post Randomization/Treatment | 46.8 percentage of arterial carbon dioxide | Standard Deviation 10.55 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | 1.50 Hours Post Randomization/Treatment | 46.0 percentage of arterial carbon dioxide | Standard Deviation 11.32 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | 1.75 Hours Post Randomization/Treatment | 44.6 percentage of arterial carbon dioxide | Standard Deviation 9.1 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | 2.00 Hours Post Randomization/Treatment | 45.3 percentage of arterial carbon dioxide | Standard Deviation 8.89 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | 2.25 Hours Post Randomization/Treatment | 47.3 percentage of arterial carbon dioxide | Standard Deviation 5.94 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | 2.50 Hours Post Randomization/Treatment | 42.4 percentage of arterial carbon dioxide | Standard Deviation 10.95 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | 2.75 Hours Post Randomization/Treatment | 46.0 percentage of arterial carbon dioxide | Standard Deviation 4.73 |
| Aerosolized Lucinactant (75 mg/kg) | PCO2 | 3.00 Hours Post Randomization/Treatment | 45.2 percentage of arterial carbon dioxide | Standard Deviation 5.19 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | At Randomization | 49.6 percentage of arterial carbon dioxide | Standard Deviation 10.73 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | 2.00 Hours Post Randomization/Treatment | 46.9 percentage of arterial carbon dioxide | Standard Deviation 9.24 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | 1.25 Hours Post Randomization/Treatment | 44.3 percentage of arterial carbon dioxide | Standard Deviation 10.74 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | At Initiation of Treatment | 46.6 percentage of arterial carbon dioxide | Standard Deviation 11.35 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | 2.75 Hours Post Randomization/Treatment | 46.8 percentage of arterial carbon dioxide | Standard Deviation 8.29 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | 15 Minutes Post Randomization/Treatment | 45.6 percentage of arterial carbon dioxide | Standard Deviation 9.81 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | 2.25 Hours Post Randomization/Treatment | 45.6 percentage of arterial carbon dioxide | Standard Deviation 8 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | 1.50 Hours Post Randomization/Treatment | 45.6 percentage of arterial carbon dioxide | Standard Deviation 10.4 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | 60 Minutes Post Randomization/Treatment | 46.2 percentage of arterial carbon dioxide | Standard Deviation 10.02 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | 1.75 Hours Post Randomization/Treatment | 46.7 percentage of arterial carbon dioxide | Standard Deviation 8.73 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | 45 Minutes Post Randomization/Treatment | 45.1 percentage of arterial carbon dioxide | Standard Deviation 10.27 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | 2.50 Hours Post Randomization/Treatment | 46.3 percentage of arterial carbon dioxide | Standard Deviation 10 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | 30 Minutes Post Randomization/Treatment | 44.7 percentage of arterial carbon dioxide | Standard Deviation 9.62 |
| Aerosolized Lucinactant (100 mg/kg) | PCO2 | 3.00 Hours Post Randomization/Treatment | 45.9 percentage of arterial carbon dioxide | Standard Deviation 8.06 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | 1.25 Hours Post Randomization/Treatment | 52.7 percentage of arterial carbon dioxide | Standard Deviation 8.7 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | 2.75 Hours Post Randomization/Treatment | 49.9 percentage of arterial carbon dioxide | Standard Deviation 7.83 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | 1.50 Hours Post Randomization/Treatment | 52.3 percentage of arterial carbon dioxide | Standard Deviation 10.64 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | 30 Minutes Post Randomization/Treatment | 55.0 percentage of arterial carbon dioxide | Standard Deviation 4.2 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | 1.75 Hours Post Randomization/Treatment | 51.8 percentage of arterial carbon dioxide | Standard Deviation 7.8 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | 2.00 Hours Post Randomization/Treatment | 51.0 percentage of arterial carbon dioxide | Standard Deviation 8.73 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | 15 Minutes Post Randomization/Treatment | 53.0 percentage of arterial carbon dioxide | Standard Deviation 8.35 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | 2.25 Hours Post Randomization/Treatment | 52.9 percentage of arterial carbon dioxide | Standard Deviation 8.52 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | At Initiation of Treatment | 57.5 percentage of arterial carbon dioxide | Standard Deviation 6.79 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | 2.50 Hours Post Randomization/Treatment | 52.0 percentage of arterial carbon dioxide | Standard Deviation 8.09 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | At Randomization | 57.4 percentage of arterial carbon dioxide | Standard Deviation 10.28 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | 3.00 Hours Post Randomization/Treatment | 51.6 percentage of arterial carbon dioxide | Standard Deviation 7.09 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | 60 Minutes Post Randomization/Treatment | 51.6 percentage of arterial carbon dioxide | Standard Deviation 7.62 |
| Aerosolized Lucinactant (150 mg/kg) | PCO2 | 45 Minutes Post Randomization/Treatment | 52.6 percentage of arterial carbon dioxide | Standard Deviation 6.68 |
| nCPAP Alone | PCO2 | 60 Minutes Post Randomization/Treatment | 47.8 percentage of arterial carbon dioxide | Standard Deviation 7.85 |
| nCPAP Alone | PCO2 | 2.50 Hours Post Randomization/Treatment | 48.2 percentage of arterial carbon dioxide | Standard Deviation 7.64 |
| nCPAP Alone | PCO2 | At Randomization | 49.2 percentage of arterial carbon dioxide | Standard Deviation 12.1 |
| nCPAP Alone | PCO2 | 1.25 Hours Post Randomization/Treatment | 47.5 percentage of arterial carbon dioxide | Standard Deviation 8.65 |
| nCPAP Alone | PCO2 | 45 Minutes Post Randomization/Treatment | 47.1 percentage of arterial carbon dioxide | Standard Deviation 9.67 |
| nCPAP Alone | PCO2 | 30 Minutes Post Randomization/Treatment | 48.1 percentage of arterial carbon dioxide | Standard Deviation 9.84 |
| nCPAP Alone | PCO2 | 3.00 Hours Post Randomization/Treatment | 46.3 percentage of arterial carbon dioxide | Standard Deviation 7.01 |
| nCPAP Alone | PCO2 | 2.75 Hours Post Randomization/Treatment | 47.3 percentage of arterial carbon dioxide | Standard Deviation 6.94 |
| nCPAP Alone | PCO2 | 2.25 Hours Post Randomization/Treatment | 48.2 percentage of arterial carbon dioxide | Standard Deviation 8.56 |
| nCPAP Alone | PCO2 | 1.50 Hours Post Randomization/Treatment | 47.9 percentage of arterial carbon dioxide | Standard Deviation 7.12 |
| nCPAP Alone | PCO2 | 2.00 Hours Post Randomization/Treatment | 48.8 percentage of arterial carbon dioxide | Standard Deviation 5.9 |
| nCPAP Alone | PCO2 | 15 Minutes Post Randomization/Treatment | 49.5 percentage of arterial carbon dioxide | Standard Deviation 10.82 |
| nCPAP Alone | PCO2 | 1.75 Hours Post Randomization/Treatment | 48.1 percentage of arterial carbon dioxide | Standard Deviation 6.46 |