Trial Outcomes & Findings for Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome (NCT NCT00004500)
NCT ID: NCT00004500
Last Updated: 2012-05-03
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
69 participants
Primary outcome timeframe
28 days
Results posted on
2012-05-03
Participant Flow
Recruitment occurred between March 2000 and October 2002. Infants were enrolled from neonatal intensive care units and were randomized to open-label study treatment.
Participant milestones
| Measure |
Lucinactant
Lucinactant via bronchoaveolar lavage
|
Standard Care
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
31
|
|
Overall Study
1 Year Follow-Up
|
24
|
24
|
|
Overall Study
COMPLETED
|
38
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
Baseline characteristics by cohort
| Measure |
Lucinactant
n=38 Participants
Lucinactant via bronchoaveolar lavage
|
Standard Care
n=31 Participants
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
38 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
31 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Gestational Age
|
40.0 weeks
STANDARD_DEVIATION 1.30 • n=5 Participants
|
39.7 weeks
STANDARD_DEVIATION 1.09 • n=7 Participants
|
39.9 weeks
STANDARD_DEVIATION 1.21 • n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: 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).
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.
Outcome measures
| Measure |
Lucinactant
n=38 Participants
Lucinactant via bronchoaveolar lavage
|
Standard Care
n=31 Participants
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
|
|---|---|---|
|
Number of Days Receiving Mechanical Ventilation (MV)
|
10.2 days
Standard Deviation 9.96
|
8.1 days
Standard Deviation 8.52
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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).
Outcome measures
| Measure |
Lucinactant
n=38 Participants
Lucinactant via bronchoaveolar lavage
|
Standard Care
n=31 Participants
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
|
|---|---|---|
|
Incidence of Death
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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).
Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium
Outcome measures
| Measure |
Lucinactant
n=38 Participants
Lucinactant via bronchoaveolar lavage
|
Standard Care
n=31 Participants
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
|
|---|---|---|
|
Number of Participants With Air Leaks
|
2 participants
|
0 participants
|
Adverse Events
Lucinactant
Serious events: 23 serious events
Other events: 36 other events
Deaths: 0 deaths
Standard Care
Serious events: 14 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lucinactant
n=38 participants at risk
Lucinactant via bronchoaveolar lavage
|
Standard Care
n=31 participants at risk
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
|
|---|---|---|
|
Cardiac disorders
Bradycardia NOS
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Cardiac disorders
Cardiac arrest
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Cardiac disorders
Cardiac tamponade
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Cardiac disorders
Cardiomyopathy NOS
|
0.00%
0/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
General disorders
Drug withdrawal syndrome
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
General disorders
Pyrexia
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Investigations
Oxygen saturation decreased
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Metabolism and nutrition disorders
Acid-base balance disorder mixed
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Metabolism and nutrition disorders
Feeding Disorder NOS
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Metabolism and nutrition disorders
Food intolerance NOS
|
0.00%
0/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Renal and urinary disorders
Renal impariment NOS
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
28.9%
11/38 • 28 Days
AEs followed until resolution or stable condition
|
19.4%
6/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Meconium aspiration
|
0.00%
0/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax NOS
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure (exc neonatal)
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Vascular disorders
Hypertension NOS
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Vascular disorders
Hypotension NOS
|
15.8%
6/38 • 28 Days
AEs followed until resolution or stable condition
|
22.6%
7/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Vascular disorders
Intraventricular haemorrhage NOS
|
0.00%
0/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Vascular disorders
Pulmonary hypertension NOS
|
28.9%
11/38 • 28 Days
AEs followed until resolution or stable condition
|
32.3%
10/31 • 28 Days
AEs followed until resolution or stable condition
|
Other adverse events
| Measure |
Lucinactant
n=38 participants at risk
Lucinactant via bronchoaveolar lavage
|
Standard Care
n=31 participants at risk
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia NOS
|
13.2%
5/38 • 28 Days
AEs followed until resolution or stable condition
|
16.1%
5/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Blood and lymphatic system disorders
Thrombocyptopenia
|
15.8%
6/38 • 28 Days
AEs followed until resolution or stable condition
|
6.5%
2/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Cardiac disorders
Bradycardia NOS
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Cardiac disorders
Cardiomegaly NOS
|
0.00%
0/38 • 28 Days
AEs followed until resolution or stable condition
|
6.5%
2/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Cardiac disorders
Pulmonary edema NOS
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Cardiac disorders
Tachycardia NOS
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
6.5%
2/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/38 • 28 Days
AEs followed until resolution or stable condition
|
6.5%
2/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
9.7%
3/31 • 28 Days
AEs followed until resolution or stable condition
|
|
General disorders
Drug withdrawn syndrome
|
10.5%
4/38 • 28 Days
AEs followed until resolution or stable condition
|
6.5%
2/31 • 28 Days
AEs followed until resolution or stable condition
|
|
General disorders
Oedema NOS
|
7.9%
3/38 • 28 Days
AEs followed until resolution or stable condition
|
6.5%
2/31 • 28 Days
AEs followed until resolution or stable condition
|
|
General disorders
Pyrexia
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Hepatobiliary disorders
Jaundice NOS
|
2.6%
1/38 • 28 Days
AEs followed until resolution or stable condition
|
6.5%
2/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Infections and infestations
Pneumonia NOS
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Infections and infestations
Sepsis NOS
|
23.7%
9/38 • 28 Days
AEs followed until resolution or stable condition
|
9.7%
3/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Investigations
Blood magnesium decreased
|
10.5%
4/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Investigations
Oxygen saturation decreased
|
10.5%
4/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Metabolism and nutrition disorders
Feeding disorder NOS
|
15.8%
6/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.4%
7/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Metabolism and nutrition disorders
Hypoglycemia NOS
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.5%
4/38 • 28 Days
AEs followed until resolution or stable condition
|
16.1%
5/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.5%
4/38 • 28 Days
AEs followed until resolution or stable condition
|
12.9%
4/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Nervous system disorders
Hypertonia
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Nervous system disorders
Hypotonia
|
7.9%
3/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Renal and urinary disorders
Oliguria
|
10.5%
4/38 • 28 Days
AEs followed until resolution or stable condition
|
6.5%
2/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Renal and urinary disorders
Renal impairment NOS
|
7.9%
3/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Atlectasis
|
13.2%
5/38 • 28 Days
AEs followed until resolution or stable condition
|
12.9%
4/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
7.9%
3/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
19/38 • 28 Days
AEs followed until resolution or stable condition
|
35.5%
11/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax NOS
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
0.00%
0/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
10.5%
4/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure (exc neonatal)
|
7.9%
3/38 • 28 Days
AEs followed until resolution or stable condition
|
12.9%
4/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
9.7%
3/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
9.7%
3/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/38 • 28 Days
AEs followed until resolution or stable condition
|
6.5%
2/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Surgical and medical procedures
Procedural site reaction
|
5.3%
2/38 • 28 Days
AEs followed until resolution or stable condition
|
6.5%
2/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Vascular disorders
Hypertension NOS
|
18.4%
7/38 • 28 Days
AEs followed until resolution or stable condition
|
3.2%
1/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Vascular disorders
Hypotension NOS
|
52.6%
20/38 • 28 Days
AEs followed until resolution or stable condition
|
41.9%
13/31 • 28 Days
AEs followed until resolution or stable condition
|
|
Vascular disorders
Pulmonary hypertension NOS
|
39.5%
15/38 • 28 Days
AEs followed until resolution or stable condition
|
35.5%
11/31 • 28 Days
AEs followed until resolution or stable condition
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60