Trial · NCT00004500

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

NCT00004500, Phase 3, Terminated, Windtree Therapeutics; results first posted 2012-05-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome. Trials, record NCT00004500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00004500

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
NCT number: NCT00004500
Status: Terminated
Phases: Phase 3
Enrollment: 69 participants, actual
Lead sponsor: Windtree Therapeutics
Conditions: Meconium Aspiration
Interventions: Lucinactant, Standard Care
First posted: 1999-10-19
Last updated: 2012-05-03
Results first posted: 2012-05-01
Limitations and caveats: Early termination led to a small number of subjects analyzed. Results should be interpreted with caution.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Days Receiving Mechanical Ventilation (MV)	28 days	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.
Secondary	Incidence of Death	28 days
Secondary	Number of Participants With Air Leaks	28 days	Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Days Receiving Mechanical Ventilation (MV)	28 days	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).	days	MEAN
SECONDARY	Incidence of Death	28 days	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).	participants	NUMBER
SECONDARY	Number of Participants With Air Leaks	28 days	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).	participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Days Receiving Mechanical Ventilation (MV)	Lucinactant	10.2	Standard Deviation 9.96	days
Number of Days Receiving Mechanical Ventilation (MV)	Standard Care	8.1	Standard Deviation 8.52	days
Incidence of Death	Lucinactant	0		participants
Incidence of Death	Standard Care	0		participants
Number of Participants With Air Leaks	Lucinactant	2		participants
Number of Participants With Air Leaks	Standard Care	0		participants

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lucinactant	38
Overall Study	STARTED	Standard Care	31
Overall Study	1 Year Follow-Up	Lucinactant	24
Overall Study	1 Year Follow-Up	Standard Care	24
Overall Study	COMPLETED	Lucinactant	38
Overall Study	COMPLETED	Standard Care	31
Overall Study	NOT COMPLETED	Lucinactant	0
Overall Study	NOT COMPLETED	Standard Care	0

Source ClinicalTrials.gov

Adverse events126

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia NOS	Blood and lymphatic system disorders	Lucinactant	5	38
other	Anemia NOS	Blood and lymphatic system disorders	Standard Care	5	31
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Lucinactant	2	38
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Standard Care	0	31
other	Thrombocyptopenia	Blood and lymphatic system disorders	Lucinactant	6	38
other	Thrombocyptopenia	Blood and lymphatic system disorders	Standard Care	2	31
other	Bradycardia NOS	Cardiac disorders	Lucinactant	2	38
other	Bradycardia NOS	Cardiac disorders	Standard Care	1	31
other	Cardiomegaly NOS	Cardiac disorders	Lucinactant	0	38
other	Cardiomegaly NOS	Cardiac disorders	Standard Care	2	31

1 to 10 of 126Source ClinicalTrials.gov

See all 126 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lucinactant
Total, all-cause mortality	Standard Care
Total, other adverse events	Lucinactant	36	38
Total, other adverse events	Standard Care	25	31
Total, serious adverse events	Lucinactant	23	38
Total, serious adverse events	Standard Care	14	31

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Lucinactant vs Standard Care: Incidence of Death	Trial comparisons
Lucinactant vs Standard Care: Number of Participants With Air Leaks	Trial comparisons
Lucinactant vs Standard Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00004500

GET https://conductscience.org/api/trials/v1/NCT00004500/events?page=2

API reference For AI assistants