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Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old (KL4-AHRF-01)

Primary Purpose

Acute Hypoxemic Respiratory Failure

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Lucinactant

Sham Comparator

About this trial

This is an interventional treatment trial for Acute Hypoxemic Respiratory Failure

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥ 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

Exclusion Criteria:

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
Meconium aspiration syndrome
Bordetella pertussis infection confirmed via laboratory tests and/or highly suspected pertussis infection

Sites / Locations

Call for information
Call for Information
Call For Information

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Lucinactant

Sham Air

Arm Description

SURFAXIN® (lucinactant) for intratracheal instillation

Sham air (placebo) instillation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00578734

First Posted

December 19, 2007

Last Updated

May 1, 2012

Sponsor

Windtree Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00578734

Brief Title

Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old

Acronym

KL4-AHRF-01

Official Title

A Multicenter, Randomized, Masked, Placebo-Controlled Trial to Assess the Safety and Efficacy of Lucinactant in Acute Hypoxemic Respiratory Failure in Children Up to Two Years of Age

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Windtree Therapeutics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

Determine the safety and tolerability of administration of a peptide-containing synthetic lung surfactant, lucinactant, in children up to two years of age and assess whether treatment with lucinactant can decrease the duration of mechanical ventilation in young children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Hypoxemic Respiratory Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lucinactant

Arm Type

Experimental

Arm Description

SURFAXIN® (lucinactant) for intratracheal instillation

Arm Title

Sham Air

Arm Type

Sham Comparator

Arm Description

Sham air (placebo) instillation

Intervention Type

Drug

Intervention Name(s)

Lucinactant

Other Intervention Name(s)

SURFAXIN®, Surfactant

Intervention Description

Slow intra-tracheal instillation

Intervention Type

Other

Intervention Name(s)

Sham Comparator

Other Intervention Name(s)

Placebo

Intervention Description

Slow intra-tracheal instillation

Primary Outcome Measure Information:

Title

Duration of Mechanical Ventilation Through 14 Days

Description

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

Time Frame

Up to 14 Days

Secondary Outcome Measure Information:

Title

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

Time Frame

Up to 14 days

10. Eligibility

Sex

All

Maximum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥ 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 Exclusion Criteria: 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 Meconium aspiration syndrome Bordetella pertussis infection confirmed via laboratory tests and/or highly suspected pertussis infection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neal Thomas, MD

Organizational Affiliation

Milton S. Hershey Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Adrienne Randolph, MD

Organizational Affiliation

Boston Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Call for information

City

Warrington

State/Province

Pennsylvania

ZIP/Postal Code

18976

Country

United States

Facility Name

Call for Information

City

Concepcion

Country

Chile

Facility Name

Call For Information

City

Santiago

Country

Chile

12. IPD Sharing Statement

Citations:

PubMed Identifier

22791092

Citation

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.

Results Reference

derived

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Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old

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