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

This study has been terminated.

(Slow enrollment)

Sponsor:

Information provided by (Responsible Party):

Discovery Laboratories

ClinicalTrials.gov Identifier:

NCT00807235

First received: December 10, 2008

Last updated: May 11, 2012

Last verified: May 2012

History of Changes

Results First Received: April 2, 2012

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Respiratory Distress Syndrome
Intervention:	Drug: Aerosolized lucinactant

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Lucinactant - 3 Hour Interval	Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
Lucinactant - 1 Hour Interval	Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour

Participant Flow: Overall Study

	Lucinactant - 3 Hour Interval	Lucinactant - 1 Hour Interval
STARTED	11	6
COMPLETED	10	6
NOT COMPLETED	1	0
Adverse Event	1	0

Baseline Characteristics

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Reporting Groups

	Description
Lucinactant - 3 Hour Interval	Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
Lucinactant - 1 Hour Interval	Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
Total	Total of all reporting groups

Baseline Measures

	Lucinactant - 3 Hour Interval	Lucinactant - 1 Hour Interval	Total
Number of Participants [units: participants]	11	6	17
Age [units: participants]
<=18 years	11	6	17
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Gender [units: participants]
Female	7	2	9
Male	4	4	8
Region of Enrollment [units: participants]
United States	11	6	17
Gestational Age [units: weeks] Mean ± Standard Deviation	29.8 ± 1.40	30.7 ± 0.99	30.1 ± 1.31

Outcome Measures

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1. Primary:

Number of Participants With Respiratory Distress Syndrome [ Time Frame: 24 hours ]

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2. Secondary:

Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂) [ Time Frame: 0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours ]

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3. Secondary:

Arterial Alveolar (a/A) O₂Ratio [ Time Frame: 72 hours ]

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4. Secondary:

Time to Meet Failure Criteria [ Time Frame: Through 28 days ]

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5. Secondary:

Number of Participants With Bronchopulmonary Dysplasia (BPD) [ Time Frame: 28 days ]

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6. Secondary:

Number of Participants Alive and Without BPD [ Time Frame: 28 days ]

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7. Secondary:

Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL) [ Time Frame: 28 days ]

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8. Secondary:

Number of Participants With Patent Ductus Arteriosus (PDA) [ Time Frame: 28 days ]

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9. Secondary:

Number of Participants With Necrotizing Enterocolitis (NEC) [ Time Frame: 28 days ]

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10. Secondary:

Number of Participants With Pulmonary Hemorrhage [ Time Frame: 28 days ]

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11. Secondary:

Number of Participants With Acquired Sepsis [ Time Frame: 28 days ]

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Measure Type	Secondary
Measure Title	Number of Participants With Acquired Sepsis
Measure Description	No text entered.
Time Frame	28 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed. All enrolled infants analyzed (intent-to-treat).

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.

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

Reporting Groups

	Description
Lucinactant - 3 Hour Interval	Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
Lucinactant - 1 Hour Interval	Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour

Measured Values

	Lucinactant - 3 Hour Interval	Lucinactant - 1 Hour Interval
Number of Participants Analyzed [units: participants]	11	6
Number of Participants With Acquired Sepsis [units: participants]	2	1

No statistical analysis provided for Number of Participants With Acquired Sepsis

12. Secondary:

Incidence of Mortality [ Time Frame: 28 days ]

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13. Secondary:

Number of Participants With Air Leak [ Time Frame: 28 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Robert Segal, MD
Organization: Discovery Laboratories, Inc.
phone: 215-488-9300
e-mail: rsegal@discoverylabs.com

Publications of Results:

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

Responsible Party:	Discovery Laboratories
ClinicalTrials.gov Identifier:	NCT00807235 History of Changes
Other Study ID Numbers:	KL4-CPAP-01
Study First Received:	December 10, 2008
Results First Received:	April 2, 2012
Last Updated:	May 11, 2012
Health Authority:	United States: Food and Drug Administration

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