NCT00578734

Brief Summary

Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if treatment with lucinactant will reduce the number of days a child needs mechanical ventilation (life support).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2007

Typical duration for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

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

June 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 27, 2012

Completed
Last Updated

May 3, 2012

Status Verified

May 1, 2012

Enrollment Period

2.8 years

First QC Date

December 19, 2007

Results QC Date

April 2, 2012

Last Update Submit

May 1, 2012

Conditions

Acute Hypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Duration of Mechanical Ventilation Through 14 Days

    Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.

    Up to 14 Days

Secondary Outcomes (1)

  • Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days

    Up to 14 days

Study Arms (2)

Lucinactant

EXPERIMENTAL

SURFAXIN® (lucinactant) for intratracheal instillation

Drug: Lucinactant

Sham Air

SHAM COMPARATOR

Sham air (placebo) instillation

Other: Sham Comparator

Interventions

LucinactantDRUG

Slow intra-tracheal instillation

Also known as: SURFAXIN®, Surfactant
Lucinactant
Sham ComparatorOTHER

Slow intra-tracheal instillation

Also known as: Placebo
Sham Air

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ≥ 38 weeks (corrected age) to 2 years (24 months)
  • Intubated and mechanically ventilated (MV) for ≥ 6 hours and anticipated need for MV for ≥ 24 hours
  • Persistent hypoxia
  • Written informed consent

You may not qualify if:

  • Mechanical Ventilation for \> 48 hours
  • Oxygenation index ≥ 25, if arterial line was avialable
  • Pre-existing clinically significant or palliated/uncorrected cardiac disease adversely affecting cardiopulmonary function and gas exchange
  • Neuromuscular disease or hypotonia
  • Upper airway disease
  • Baseline requirment for supplemental oxygen
  • Untreated pneumothorax
  • Off-label use of commercially available surfactant outside neonatal period
  • History of prematurity and passive immunoprophylaxis with humanized monoclonal antibody
  • Head injury with Glasgow Coma Scale \< 8
  • Brain death or impending brain death
  • Do not resuscitate orders
  • Cardiopulmonary resuscitation within 6 hours of meeting entry criteria
  • Experimental therapy in which the intervention potentially affects respiratory outcomes
  • Any transplant recipient
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Call for information

Warrington, Pennsylvania, 18976, United States

Location

Call for Information

Concepción, Chile

Location

Call For Information

Santiago, Chile

Location

Related Publications (1)

  • Thomas NJ, Guardia CG, Moya FR, Cheifetz IM, Markovitz B, Cruces P, Barton P, Segal R, Simmons P, Randolph AG; PALISI Network. A pilot, randomized, controlled clinical trial of lucinactant, a peptide-containing synthetic surfactant, in infants with acute hypoxemic respiratory failure. Pediatr Crit Care Med. 2012 Nov;13(6):646-53. doi: 10.1097/PCC.0b013e3182517bec.

    PMID: 22791092DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

lucinactantSurface-Active Agents

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and Uses

Results Point of Contact

Title
Dr. Neal J. Thomas
Organization
Penn State Children's Hospital
nthomas@hmc.psu.edu
717-531-5337

Study Officials

  • Neal Thomas, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

  • Adrienne Randolph, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 21, 2007

Study Start

June 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 3, 2012

Results First Posted

April 27, 2012

Record last verified: 2012-05

Locations

US(1)CL(2)