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TerminatedNCT00807235Updated Jun 13, 2012Results posted

Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants

A Phase 2 interventional study of Aerosolized lucinactant and Aerosolized lucinactant in Respiratory Distress Syndrome, sponsored by Windtree Therapeutics. Terminated at 1 site in United States. Open to participants aged 15 Minutes to 30 Minutes. Per ClinicalTrials.gov, last updated 2012-06-13.

Sponsored by Windtree Therapeutics · Phase 2, Interventional, and Prevention

Why this study was terminated
Slow enrollment
Phase
Phase 2
Study type
Interventional
Enrollment
17
Allocation
Non-randomized
Ages
15 Minutes to 30 Minutes
Sex
All
01

Study summary

To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.

Read the detailed description

Use of a device in the early treatment of RDS that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. This approach could reduce the frequency of severity of the adverse events relative to endotracheal intubation and surfactant administration via bolus.

02

Conditions studied

  • Respiratory Distress Syndrome

Keywords

  • Lucinactant
  • Nasal continuous positive airway pressure (nCPAP)
  • Respiratory distress syndrome (RDS)
  • Pediatric
  • Premature
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 17 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Windtree Therapeutics is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Minutes to 30 Minutes
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Gestational age 28-32 completed weeks, inclusive
  • Placement of arterial line
  • Successful initiation of nCPAP
  • Informed Consent

Exclusion criteria

Exclusion Criteria:

  • Heart rate that cannot be stabilized >100 bpm within 5 minutes of birth
  • Five (5) minute Apgar score ≤ 3
  • Major congenital malformation(s) diagnosed antenatally or noted immediately after birth
  • Other disease(s) or conditions potentially interfering with cardiopulmonary function
  • Mother with prolonged rupture of membranes > 2 weeks
  • Known or suspected chromosomal abnormality
  • Need for chest compressions or administration of epinephrine, bicarbonate, or fluid boluses in the delivery room
  • Need for mechanical ventilation within 30 minutes of birth
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Regimen 1

    Drug: Aerosolized lucinactant

  • Experimental
    Regimen 2

    Drug: Aerosolized lucinactant

Interventions

  • DrugAerosolized lucinactant

    Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours.

    Also known as: KL₄Surfactant

  • DrugAerosolized lucinactant

    Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 1 hour.

    Also known as: KL₄Surfactant

06

What researchers measure

Primary outcomes

  1. Number of Participants With Respiratory Distress Syndrome

    Time frame: 24 hours

Secondary outcomes

  1. Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)

    AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward

    Time frame: 0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours

  2. Arterial Alveolar (a/A) O₂Ratio

    a/A ratio is a relative way to judge the lungs ability to transport O₂. It compares the partial pressure of O₂in the alveoli (A) to the partial pressure of O₂in the artery (a). It is calculated by dividing the partial pressure of O₂in the artery, abbreviated PaO2, by the partial pressure of O₂in the alveoli using the alveolar gas equation, abbreviated PAO2. A value of 0.80 or above is normal, a value of 0.60 or below may be incompatible with spontaneous breathing, and a value below 0.22 indicates severe lung disease.

    Time frame: 72 hours

  3. Time to Meet Failure Criteria

    Failure criteria defined as rescue with bolus surfactant and mechanical ventilation

    Time frame: Through 28 days

  4. Number of Participants With Bronchopulmonary Dysplasia (BPD)

    Time frame: 28 days

  5. Number of Participants Alive and Without BPD

    Time frame: 28 days

  6. Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)

    Time frame: 28 days

  7. Number of Participants With Patent Ductus Arteriosus (PDA)

    Time frame: 28 days

  8. Number of Participants With Necrotizing Enterocolitis (NEC)

    Time frame: 28 days

  9. Number of Participants With Pulmonary Hemorrhage

    Time frame: 28 days

  10. Number of Participants With Acquired Sepsis

    Time frame: 28 days

  11. Incidence of Mortality

    Time frame: 28 days

  12. Number of Participants With Air Leak

    Time frame: 28 days

07

Results

Posted Jun 13, 2012

Participant flow

Neonates were enrolled between January and August, 2005. This was an open-label study with 2 treatment groups (Regimen 1 and Regimen 2). Eligible neonates were sequentially enrolled and stratified by GA into 2 strata for each regimen. For each regimen, enrollment in Stratum 1 (30 to 32 GA) was completed before enrollment in Stratum 2 (28 to 29 GA).

Participant flow — Overall Study
MilestoneLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Started116
Completed106
Not completed10
Withdrew: Adverse event10

Outcome measures

PrimaryNumber of Participants With Respiratory Distress Syndrome
Time frame:
24 hours
Reported as:
Number · participants
Number of Participants With Respiratory Distress Syndrome
participantsLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Number of Participants With Respiratory Distress Syndrome40
SecondaryArea Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)

AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward

Time frame:
0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours
Reported as:
Mean · percent O₂*hours
Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)
percent O₂*hoursLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)0.36 ± 0.150.25 ± 0.08
SecondaryArterial Alveolar (a/A) O₂Ratio

a/A ratio is a relative way to judge the lungs ability to transport O₂. It compares the partial pressure of O₂in the alveoli (A) to the partial pressure of O₂in the artery (a). It is calculated by dividing the partial pressure of O₂in the artery, abbreviated PaO2, by the partial pressure of O₂in the alveoli using the alveolar gas equation, abbreviated PAO2. A value of 0.80 or above is normal, a value of 0.60 or below may be incompatible with spontaneous breathing, and a value below 0.22 indicates severe lung disease.

Time frame:
72 hours
Reported as:
Mean · mm Hg over mm Hg (ratio of pressures)
Arterial Alveolar (a/A) O₂Ratio
mm Hg over mm Hg (ratio of pressures)Lucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Arterial Alveolar (a/A) O₂Ratio0.46 ± 0.250.53 ± 0.29
SecondaryTime to Meet Failure Criteria

Failure criteria defined as rescue with bolus surfactant and mechanical ventilation

Time frame:
Through 28 days
Reported as:
Mean · days
Time to Meet Failure Criteria
daysLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Time to Meet Failure Criteria0.49 ± 0.380.30 ± 0.35
SecondaryNumber of Participants With Bronchopulmonary Dysplasia (BPD)
Time frame:
28 days
Reported as:
Number · participants
Number of Participants With Bronchopulmonary Dysplasia (BPD)
participantsLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Number of Participants With Bronchopulmonary Dysplasia (BPD)11
SecondaryNumber of Participants Alive and Without BPD
Time frame:
28 days
Reported as:
Number · participants
Number of Participants Alive and Without BPD
participantsLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Number of Participants Alive and Without BPD105
SecondaryNumber of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)
Time frame:
28 days
Reported as:
Number · participants
Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)
participantsLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)10
SecondaryNumber of Participants With Patent Ductus Arteriosus (PDA)
Time frame:
28 days
Reported as:
Number · participants
Number of Participants With Patent Ductus Arteriosus (PDA)
participantsLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Number of Participants With Patent Ductus Arteriosus (PDA)33
SecondaryNumber of Participants With Necrotizing Enterocolitis (NEC)
Time frame:
28 days
Reported as:
Number · participants
Number of Participants With Necrotizing Enterocolitis (NEC)
participantsLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Number of Participants With Necrotizing Enterocolitis (NEC)00
SecondaryNumber of Participants With Pulmonary Hemorrhage
Time frame:
28 days
Reported as:
Number · participants
Number of Participants With Pulmonary Hemorrhage
participantsLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Number of Participants With Pulmonary Hemorrhage00
SecondaryNumber of Participants With Acquired Sepsis
Time frame:
28 days
Reported as:
Number · participants
Number of Participants With Acquired Sepsis
participantsLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Number of Participants With Acquired Sepsis21
SecondaryIncidence of Mortality
Time frame:
28 days
Reported as:
Number · participants
Incidence of Mortality
participantsLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Incidence of Mortality00
SecondaryNumber of Participants With Air Leak
Time frame:
28 days
Reported as:
Number · participants
Number of Participants With Air Leak
participantsLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Number of Participants With Air Leak00

Adverse events

Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lucinactant - 3 Hour Interval—5/11 (45.5%)11/11 (100%)
Lucinactant - 1 Hour Interval—1/6 (16.7%)6/6 (100%)
Most frequent serious events
Most frequent serious events
EventLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Neonatal respiratory distress syndromeRespiratory, thoracic and mediastinal disorders3/110/6
Oxygen saturation decreasedInvestigations0/111/6
Neonatal apnoeic attackRespiratory, thoracic and mediastinal disorders0/111/6
Sepsis neonatalInfections and infestations1/110/6
Neonatal respiratory failureRespiratory, thoracic and mediastinal disorders1/110/6
Pulmonary hypertension NOSVascular disorders1/110/6
Most frequent other events
Showing 10 of 32
Most frequent other events
EventLucinactant - 3 Hour IntervalLucinactant - 1 Hour Interval
Neonatal apnoeic attachRespiratory, thoracic and mediastinal disorders10/116/6
Oxygen saturation decreasedInvestigations6/113/6
Neonatal respiratory distress syndromeRespiratory, thoracic and mediastinal disorders6/111/6
Anaemia neonatalBlood and lymphatic system disorders2/113/6
Bradycardia NOSCardiac disorders1/113/6
Patent ductus arteriosusCongenital, familial and genetic disorders4/113/6
HypocalcaemiaMetabolism and nutrition disorders4/112/6
Gastro-oesophageal reflux diseaseGastrointestinal disorders0/112/6
Jaundice neonatalHepatobiliary disorders3/111/6
HypermagnesaemiaMetabolism and nutrition disorders3/110/6

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Lucinactant - 3 Hour IntervalLucinactant - 1 Hour IntervalTotal
<=18 years11617
Between 18 and 65 years000
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Lucinactant - 3 Hour IntervalLucinactant - 1 Hour IntervalTotal
Female729
Male448
Region of Enrollment
Region of Enrollment(participants)Lucinactant - 3 Hour IntervalLucinactant - 1 Hour IntervalTotal
United States11617
Gestational Age
Gestational Age(weeks)Lucinactant - 3 Hour IntervalLucinactant - 1 Hour IntervalTotal
Mean29.8 ± 1.4030.7 ± 0.9930.1 ± 1.31
08

Study locations

1 site
  • University of California, San Diego Medical Center - Hillcrest
    San Diego, California 92103, United States
09

References and documents

Publications

  • Finer NN, Merritt TA, Bernstein G, Job L, Mazela J, Segal R. An open label, pilot study of Aerosurf(R) combined with nCPAP to prevent RDS in preterm neonates. J Aerosol Med Pulm Drug Deliv. 2010 Oct;23(5):303-9. doi: 10.1089/jamp.2009.0758. PubMed 20455772 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00807235
Lead sponsor
Windtree Therapeutics
Responsible party
Sponsor
First posted
Dec 11, 2008
Start date
Jan 2005
Primary completion
Aug 2005
Completion
Sep 2005
Results posted
Jun 13, 2012
Last update
Jun 13, 2012

Study contacts

Neil Finer, MD
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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