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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-04-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Acute Hypoxemic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lucinactant

SURFAXIN® (lucinactant) for intratracheal instillation

Group Type EXPERIMENTAL

Lucinactant

Intervention Type DRUG

Slow intra-tracheal instillation

Sham Air

Sham air (placebo) instillation

Group Type SHAM_COMPARATOR

Sham Comparator

Intervention Type OTHER

Slow intra-tracheal instillation

Interventions

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Lucinactant

Slow intra-tracheal instillation

Intervention Type DRUG

Sham Comparator

Slow intra-tracheal instillation

Intervention Type OTHER

Other Intervention Names

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SURFAXIN® Surfactant Placebo

Eligibility Criteria

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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

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No