Meconium AspirationPhase 3NCT00004500
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
A Phase 3 study testing Lucinactant in people with Meconium Aspiration, run by Windtree Therapeutics at 1 site in United States.
Trial summary
OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Meconium Aspiration
- What is being tested?
- Lucinactant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Nov 2004
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of meconium aspiration syndrome (MAS)
- Continuous mechanical ventilation (CMV) at time of entry
- Enrollment within 48 hours of birth
- Gestational age of ≥ 37 weeks
- Oxygenation index of ≥ 5 and ≤ 30
- Written informed consent signed and dated by the infant's parent(s) or legal guardian(s)
Who cannot join
- Congenital anomalies likely to affect any primary or secondary endpoints
- Uncontrollable air leaks
- Hydrops fetalis
- Rupture ≥ 3 weeks of the fetal membranes
- Evidence of overwhelming bacterial infection at time of randomization
- Markedly labile persistent pulmonary hypertension at time of randomization
- Profound neurologic manifestations
- Sustained postductal SpO₂of < 87% for ≥ 15 minutes at an FiO₂of 1.00
Trial locations and contacts
1 site in 1 country.
United States1 site
Discovery Laboratories, Inc.
Warrington, Pennsylvania, 18976
About this study
Official title: A Multicenter, Randomized, Controlled Trial Comparing the Safety and Effectiveness of Bronchoalveolar Lavage With Lucinactant to Standard Care for the Treatment of the Meconium Aspriation Syndrome (MAS) in Newborn Infants
OBJECTIVES:
Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
Read the detailed description
PROTOCOL OUTLINE:
This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive lucinactant by bronchoalveolar lavage, into the right and left lung, followed by lung drainage. Treatment repeats when patient stabilizes or every 15 minutes for 2 courses.
Arm II: Patients receive standard treatment including oxygen, conventional mechanical ventilation, sedation, paralysis, vasopressors, and alkalinization.
Patients are followed for 12 months.
- Conditions
- Meconium Aspiration
- Being tested
- Lucinactant, Standard Care
- Keywords
- cardiovascular and respiratory diseases, meconium aspiration syndrome, rare disease
- Medical subject headings
- Meconium Aspiration Syndrome, Respiratory Tract Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LucinactantDrug
Also called Surfactant, KL₄Surfactant
Lucinactant suspension was administered as 10 mg total phospholipid (TPL)/mL, by bronchoalveolar lavage within 90 minutes of randomization. The dose was determined based on the infant's body weight such that the total dose was 16 mL/kg for each of the 2 lavage procedures and 32 mL/kg overall. Infants received 2 doses of lucinactant. Each dose consisted of separate lavage procedures for each lung within 15 minutes (up to 60 minutes) of each other.
Standard CareOther
Also called Negative Control
The Standard Care (SC) group received therapies including, but not limited to, the use of oxygen, controlled mechanical ventilation (CMV), sedation, paralysis, vasopressors, and/or alkalinization. The use of adjunctive therapies (namely: high frequency oscillatory ventilation, high frequency jet ventilation, bolus surfactant, inhaled nitric oxide, extra-corporeal membrane oxygenation, or systemic corticosteroids) were not included in SC
| Study group | Role | What they receive |
|---|---|---|
| Lucinactant | Experimental | Lucinactant via bronchoaveolar lavage Receives: Drug: Lucinactant |
| Standard Care | Other | Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days Receiving Mechanical Ventilation (MV)
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.
Measured: 28 days
Secondary outcomes (2)
Incidence of Death
Measured: 28 days
Number of Participants With Air Leaks
Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startMar 2000
- Primary completionNov 2002
- Study completionNov 2004
Why it stopped: Slow enrollment and administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meconium AspirationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Windtree Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas E Wiswell, Study chair, Windtree Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004500
- Sponsor's protocol ID
- KL4-MAS-03
- Other IDs
- FD-R-001938
- Status last verified
- May 2012
- First submitted
- 18 Oct 1999
- Last updated
- 3 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Trial Comparing the Safety and Effectiveness of Bronchoalveolar Lavage With Lucinactant to Standard Care for the Treatment of the Meconium Aspriation Syndrome (MAS) in Newborn Infants
- ClinicalTrials.gov ID
- NCT00004500
- Acronym / sponsor ID
- KL4-MAS-03
- Conditions
- Meconium Aspiration
- Keywords
- cardiovascular and respiratory diseases, meconium aspiration syndrome, rare disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment and administrative reasons
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Windtree TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2000
- Primary completion
- Nov 2002 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 19 Oct 1999 (estimated)
- Results
- Posted 1 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
Detailed description
PROTOCOL OUTLINE:
This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive lucinactant by bronchoalveolar lavage, into the right and left lung, followed by lung drainage. Treatment repeats when patient stabilizes or every 15 minutes for 2 courses.
Arm II: Patients receive standard treatment including oxygen, conventional mechanical ventilation, sedation, paralysis, vasopressors, and alkalinization.
Patients are followed for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lucinactant | Experimental | Drug: LucinactantLucinactant via bronchoaveolar lavage |
| Standard Care | Other | Other: Standard CareStandard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosis of meconium aspiration syndrome (MAS)
- Continuous mechanical ventilation (CMV) at time of entry
- Enrollment within 48 hours of birth
- Gestational age of ≥ 37 weeks
- Oxygenation index of ≥ 5 and ≤ 30
Key exclusion criteria (8 listed)
- Congenital anomalies likely to affect any primary or secondary endpoints
- Uncontrollable air leaks
- Hydrops fetalis
- Rupture ≥ 3 weeks of the fetal membranes
- Evidence of overwhelming bacterial infection at time of randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LucinactantAlso: Surfactant, KL₄SurfactantLucinactant suspension was administered as 10 mg total phospholipid (TPL)/mL, by bronchoalveolar lavage within 90 minutes of randomization. The dose was determined based on the infant's body weight such that the total dose was 16 mL/kg for each of the 2 lavage procedures and 32 mL/kg overall. Infants received 2 doses of lucinactant. Each dose consisted of separate lavage procedures for each lung within 15 minutes (up to 60 minutes) of each other. | Drug | Lucinactant |
| Standard CareAlso: Negative ControlThe Standard Care (SC) group received therapies including, but not limited to, the use of oxygen, controlled mechanical ventilation (CMV), sedation, paralysis, vasopressors, and/or alkalinization. The use of adjunctive therapies (namely: high frequency oscillatory ventilation, high frequency jet ventilation, bolus surfactant, inhaled nitric oxide, extra-corporeal membrane oxygenation, or systemic corticosteroids) were not included in SC | Other | Standard Care |
Primary outcome
Number of Days Receiving Mechanical Ventilation (MV)
Time frame: 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.
2 secondary outcomes
Incidence of Death
Time frame: 28 days
Number of Participants With Air Leaks
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Meconium Aspiration
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CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)
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Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Active, not recruiting
Pulmonary Function Using Non-invasive Forced Oscillometry
Infant, Premature, Diseases, Infant, Newborn, Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas E Wiswell study chair
Windtree Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lucinactant in people with Meconium Aspiration, run by Windtree Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days Receiving Mechanical Ventilation (MV) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2012.