NCT00807235

Brief Summary

To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

June 13, 2012

Completed
Last Updated

June 13, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

December 10, 2008

Results QC Date

April 2, 2012

Last Update Submit

May 11, 2012

Conditions

Respiratory Distress Syndrome

Keywords

LucinactantNasal continuous positive airway pressure (nCPAP)Respiratory distress syndrome (RDS)PediatricPremature

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Respiratory Distress Syndrome

    24 hours

Secondary Outcomes (12)

  • Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)

    0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours

  • Arterial Alveolar (a/A) O₂Ratio

    72 hours

  • Time to Meet Failure Criteria

    Through 28 days

  • Number of Participants With Bronchopulmonary Dysplasia (BPD)

    28 days

  • Number of Participants Alive and Without BPD

    28 days

  • +7 more secondary outcomes

Study Arms (2)

Regimen 1

EXPERIMENTAL
Drug: Aerosolized lucinactant

Regimen 2

EXPERIMENTAL
Drug: Aerosolized lucinactant

Interventions

Aerosolized lucinactantDRUG

Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours.

Also known as: KL₄Surfactant
Regimen 1

Eligibility Criteria

Age15 Minutes - 30 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age 28-32 completed weeks, inclusive
  • Placement of arterial line
  • Successful initiation of nCPAP
  • Informed Consent

You may not qualify if:

  • Heart rate that cannot be stabilized \>100 bpm within 5 minutes of birth
  • Five (5) minute Apgar score ≤ 3
  • Major congenital malformation(s) diagnosed antenatally or noted immediately after birth
  • Other disease(s) or conditions potentially interfering with cardiopulmonary function
  • Mother with prolonged rupture of membranes \> 2 weeks
  • Known or suspected chromosomal abnormality
  • Need for chest compressions or administration of epinephrine, bicarbonate, or fluid boluses in the delivery room
  • Need for mechanical ventilation within 30 minutes of birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego Medical Center - Hillcrest

San Diego, California, 92103, United States

Location

Related Publications (1)

  • Finer NN, Merritt TA, Bernstein G, Job L, Mazela J, Segal R. An open label, pilot study of Aerosurf(R) combined with nCPAP to prevent RDS in preterm neonates. J Aerosol Med Pulm Drug Deliv. 2010 Oct;23(5):303-9. doi: 10.1089/jamp.2009.0758.

    PMID: 20455772RESULT

MeSH Terms

Conditions

Respiratory Distress SyndromePremature Birth

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Results Point of Contact

Title
Robert Segal, MD
Organization
Discovery Laboratories, Inc.
rsegal@discoverylabs.com
215-488-9300

Study Officials

  • Neil Finer, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2008

First Posted

December 11, 2008

Study Start

January 1, 2005

Primary Completion

August 1, 2005

Study Completion

September 1, 2005

Last Updated

June 13, 2012

Results First Posted

June 13, 2012

Record last verified: 2012-05

Locations

US(1)