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Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004500
Recruitment Status : Terminated (Slow enrollment and administrative reasons)
First Posted : October 19, 1999
Results First Posted : May 1, 2012
Last Update Posted : May 3, 2012
Sponsor:
Information provided by (Responsible Party):
Windtree Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Meconium Aspiration
Interventions Drug: Lucinactant
Other: Standard Care
Enrollment 69
Recruitment Details Recruitment occurred between March 2000 and October 2002. Infants were enrolled from neonatal intensive care units and were randomized to open-label study treatment.
Pre-assignment Details  
Arm/Group Title Lucinactant Standard Care
Hide Arm/Group Description Lucinactant via bronchoaveolar lavage Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
Period Title: Overall Study
Started 38 31
1 Year Follow-Up 24 24
Completed 38 31
Not Completed 0 0
Arm/Group Title Lucinactant Standard Care Total
Hide Arm/Group Description Lucinactant via bronchoaveolar lavage Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization Total of all reporting groups
Overall Number of Baseline Participants 38 31 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 31 participants 69 participants
<=18 years
38
 100.0%
31
 100.0%
69
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 31 participants 69 participants
Female
16
  42.1%
15
  48.4%
31
  44.9%
Male
22
  57.9%
16
  51.6%
38
  55.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants 31 participants 69 participants
38 31 69
Gestational Age  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 38 participants 31 participants 69 participants
40.0  (1.30) 39.7  (1.09) 39.9  (1.21)
1.Primary Outcome
Title Number of Days Receiving Mechanical Ventilation (MV)
Hide Description A patient is not receiving MV if he/she is removed from the mechanical ventilator for ≥ 24 hours. If a patient subsequently requires intubation and MV, the additional time will count as days receiving MV.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description

Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.

All enrolled infants were analyzed (intent-to-treat).

Arm/Group Title Lucinactant Standard Care
Hide Arm/Group Description:
Lucinactant via bronchoaveolar lavage
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
Overall Number of Participants Analyzed 38 31
Mean (Standard Deviation)
Unit of Measure: days
10.2  (9.96) 8.1  (8.52)
2.Secondary Outcome
Title Incidence of Death
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description

Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.

All enrolled infants were analyzed (intent-to-treat).

Arm/Group Title Lucinactant Standard Care
Hide Arm/Group Description:
Lucinactant via bronchoaveolar lavage
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
Overall Number of Participants Analyzed 38 31
Measure Type: Number
Unit of Measure: participants
0 0
3.Secondary Outcome
Title Number of Participants With Air Leaks
Hide Description Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description

Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.

All enrolled infants were analyzed (intent-to-treat).

Arm/Group Title Lucinactant Standard Care
Hide Arm/Group Description:
Lucinactant via bronchoaveolar lavage
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
Overall Number of Participants Analyzed 38 31
Measure Type: Number
Unit of Measure: participants
2 0
Time Frame 28 Days
Adverse Event Reporting Description AEs followed until resolution or stable condition
 
Arm/Group Title Lucinactant Standard Care
Hide Arm/Group Description Lucinactant via bronchoaveolar lavage Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
All-Cause Mortality
Lucinactant Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lucinactant Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   23/38 (60.53%)   14/31 (45.16%) 
Cardiac disorders     
Bradycardia NOS  1  1/38 (2.63%)  0/31 (0.00%) 
Cardiac arrest  1  1/38 (2.63%)  0/31 (0.00%) 
Cardiac tamponade  1  1/38 (2.63%)  1/31 (3.23%) 
Cardiomyopathy NOS  1  0/38 (0.00%)  1/31 (3.23%) 
Gastrointestinal disorders     
Dysphagia  1  1/38 (2.63%)  0/31 (0.00%) 
General disorders     
Drug withdrawal syndrome  1  2/38 (5.26%)  1/31 (3.23%) 
Pyrexia  1  1/38 (2.63%)  0/31 (0.00%) 
Investigations     
Oxygen saturation decreased  1  1/38 (2.63%)  0/31 (0.00%) 
Metabolism and nutrition disorders     
Acid-base balance disorder mixed  1  1/38 (2.63%)  0/31 (0.00%) 
Feeding Disorder NOS  1  1/38 (2.63%)  0/31 (0.00%) 
Food intolerance NOS  1  0/38 (0.00%)  1/31 (3.23%) 
Renal and urinary disorders     
Renal impariment NOS  1  2/38 (5.26%)  0/31 (0.00%) 
Renal infarct  1  0/38 (0.00%)  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders     
Bronchopulmonary dysplasia  1  1/38 (2.63%)  0/31 (0.00%) 
Hypoxia  1  11/38 (28.95%)  6/31 (19.35%) 
Meconium aspiration  1  0/38 (0.00%)  1/31 (3.23%) 
Pneumothorax NOS  1  1/38 (2.63%)  0/31 (0.00%) 
Pulmonary Haemorrhage  1  2/38 (5.26%)  0/31 (0.00%) 
Respiratory failure (exc neonatal)  1  1/38 (2.63%)  1/31 (3.23%) 
Stridor  1  1/38 (2.63%)  0/31 (0.00%) 
Vascular disorders     
Hypertension NOS  1  1/38 (2.63%)  0/31 (0.00%) 
Hypotension NOS  1  6/38 (15.79%)  7/31 (22.58%) 
Intraventricular haemorrhage NOS  1  0/38 (0.00%)  1/31 (3.23%) 
Pulmonary hypertension NOS  1  11/38 (28.95%)  10/31 (32.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lucinactant Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   36/38 (94.74%)   25/31 (80.65%) 
Blood and lymphatic system disorders     
Anemia NOS  1  5/38 (13.16%)  5/31 (16.13%) 
Disseminated intravascular coagulation  1  2/38 (5.26%)  0/31 (0.00%) 
Thrombocyptopenia  1  6/38 (15.79%)  2/31 (6.45%) 
Cardiac disorders     
Bradycardia NOS  1  2/38 (5.26%)  1/31 (3.23%) 
Cardiomegaly NOS  1  0/38 (0.00%)  2/31 (6.45%) 
Pulmonary edema NOS  1  2/38 (5.26%)  0/31 (0.00%) 
Tachycardia NOS  1  2/38 (5.26%)  2/31 (6.45%) 
Tricuspid valve incompetence  1  0/38 (0.00%)  2/31 (6.45%) 
Congenital, familial and genetic disorders     
Patent ductus arteriosus  1  1/38 (2.63%)  3/31 (9.68%) 
General disorders     
Drug withdrawn syndrome  1  4/38 (10.53%)  2/31 (6.45%) 
Oedema NOS  1  3/38 (7.89%)  2/31 (6.45%) 
Pyrexia  1  2/38 (5.26%)  1/31 (3.23%) 
Hepatobiliary disorders     
Jaundice NOS  1  1/38 (2.63%)  2/31 (6.45%) 
Infections and infestations     
Pneumonia NOS  1  2/38 (5.26%)  0/31 (0.00%) 
Sepsis NOS  1  9/38 (23.68%)  3/31 (9.68%) 
Investigations     
Blood magnesium decreased  1  4/38 (10.53%)  1/31 (3.23%) 
Oxygen saturation decreased  1  4/38 (10.53%)  1/31 (3.23%) 
Metabolism and nutrition disorders     
Feeding disorder NOS  1  6/38 (15.79%)  1/31 (3.23%) 
Hypocalcemia  1  7/38 (18.42%)  1/31 (3.23%) 
Hypoglycemia NOS  1  2/38 (5.26%)  0/31 (0.00%) 
Hypokalemia  1  4/38 (10.53%)  5/31 (16.13%) 
Hyponatremia  1  4/38 (10.53%)  4/31 (12.90%) 
Nervous system disorders     
Hypertonia  1  2/38 (5.26%)  0/31 (0.00%) 
Hypotonia  1  3/38 (7.89%)  0/31 (0.00%) 
Renal and urinary disorders     
Oliguria  1  4/38 (10.53%)  2/31 (6.45%) 
Renal impairment NOS  1  3/38 (7.89%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Atlectasis  1  5/38 (13.16%)  4/31 (12.90%) 
Bronchopulmonary dysplasia  1  3/38 (7.89%)  0/31 (0.00%) 
Hypoxia  1  19/38 (50.00%)  11/31 (35.48%) 
Pneumothorax NOS  1  2/38 (5.26%)  0/31 (0.00%) 
Pulmonary haemorrhage  1  4/38 (10.53%)  1/31 (3.23%) 
Respiratory failure (exc neonatal)  1  3/38 (7.89%)  4/31 (12.90%) 
Stridor  1  2/38 (5.26%)  3/31 (9.68%) 
Tachypnea  1  2/38 (5.26%)  3/31 (9.68%) 
Skin and subcutaneous tissue disorders     
Rash erythematous  1  0/38 (0.00%)  2/31 (6.45%) 
Surgical and medical procedures     
Procedural site reaction  1  2/38 (5.26%)  2/31 (6.45%) 
Vascular disorders     
Hypertension NOS  1  7/38 (18.42%)  1/31 (3.23%) 
Hypotension NOS  1  20/38 (52.63%)  13/31 (41.94%) 
Pulmonary hypertension NOS  1  15/38 (39.47%)  11/31 (35.48%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Early termination led to a small number of subjects analyzed. Results should be interpreted with caution.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert Segal
Organization: Discovery Laboratories, Inc.
Phone: 215-488-9300
EMail: rsegal@discoverylabs.com
Layout table for additonal information
Responsible Party: Windtree Therapeutics
ClinicalTrials.gov Identifier: NCT00004500     History of Changes
Other Study ID Numbers: KL4-MAS-03
FD-R-001938 ( Other Grant/Funding Number: US Department of Health and Human Services )
First Submitted: October 18, 1999
First Posted: October 19, 1999
Results First Submitted: April 2, 2012
Results First Posted: May 1, 2012
Last Update Posted: May 3, 2012