CompletedNCT00578734KL4-AHRF-01Updated May 3, 2012Results posted

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

A Phase 2 interventional study of Lucinactant and Sham Comparator in Acute Hypoxemic Respiratory Failure, sponsored by Windtree Therapeutics. Completed at 3 sites in 2 countries. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2012-05-03.

Sponsored by Windtree Therapeutics · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 165
Allocation: Randomized
Ages: Up to 2 Years
Sex: All

Study 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).

Read the 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.

Conditions studied

Acute Hypoxemic Respiratory Failure

Browse trials for

Respiratory Insufficiency 1,650

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 165 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Windtree Therapeutics is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 2 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 165 participants (actual)

Study arms

Experimental
Lucinactant
SURFAXIN® (lucinactant) for intratracheal instillation
Drug: Lucinactant
Sham comparator
Sham Air
Sham air (placebo) instillation
Other: Sham Comparator

Interventions

DrugLucinactant
Slow intra-tracheal instillation
Also known as: SURFAXIN®, Surfactant
OtherSham Comparator
Slow intra-tracheal instillation
Also known as: Placebo

What researchers measure

Primary outcomes

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.
Time frame: Up to 14 Days

Secondary outcomes

Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days
Time frame: Up to 14 days

Results

Posted Apr 27, 2012

Participant flow

Subjects were enrolled at 24 hospitals in the United States and Chile from 04 June, 2007 to 23 March, 2010. Last subject's last visit occurred on 05 April, 2010.

Participant flow — Overall Study
Milestone	Lucinactant	Sham Air
Started	84	81
Completed	84	81
Not completed	0	0

Outcome measures

PrimaryDuration 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.

Time frame:: Up to 14 Days
Reported as:: Least squares mean · days

Duration of Mechanical Ventilation Through 14 Days
days	Lucinactant	Sham Air
Duration of Mechanical Ventilation Through 14 Days	4.0 (3.5 to 4.6)	4.5 (3.9 to 5.2)

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

Time frame:: Up to 14 days
Reported as:: Least squares mean · days

Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days
days	Lucinactant	Sham Air
Ventilator-free days	5.2 (4.6 to 5.9)	4.6 (4.1 to 5.3)
Duration in Pediatric Intensive Care Unit (PICU)	6.2 (5.4 to 7.0)	6.7 (5.9 to 7.6)
Duration of Supplemental Oxygen	7.7 (6.8 to 8.7)	7.9 (7.0 to 9.0)
Duration of Hospitalization	10.0 (9.1 to 11.1)	9.7 (8.8 to 10.7)

Adverse events

Collected over 14 days from randomization or until resolution of adverse events.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Lucinactant	—	20/84 (23.8%)	65/84 (77.4%)
Sham Air	—	14/81 (17.3%)	62/81 (76.5%)

Most frequent serious events

Showing 10 of 24

Most frequent serious events
Event	Lucinactant	Sham Air
PneumoniaInfections and infestations	5/84	0/81
PneumothoraxRespiratory, thoracic and mediastinal disorders	5/84	3/81
ApnoeaRespiratory, thoracic and mediastinal disorders	0/84	2/81
BradycardiaCardiac disorders	1/84	2/81
Endotracheal intubation complicationInjury, poisoning and procedural complications	1/84	2/81
LaryngitisRespiratory, thoracic and mediastinal disorders	0/84	2/81
Oxygen saturation decreasedInvestigations	2/84	2/81
SepsisInfections and infestations	2/84	1/81
Cardiac arrestCardiac disorders	0/84	1/81
AbscessInfections and infestations	0/84	1/81

Most frequent other events

Showing 10 of 25

Most frequent other events
Event	Lucinactant	Sham Air
HypokalaemiaMetabolism and nutrition disorders	23/84	17/81
AnaemiaBlood and lymphatic system disorders	11/84	19/81
AtelectasisRespiratory, thoracic and mediastinal disorders	11/84	13/81
HypotensionVascular disorders	8/84	12/81
HypoalbuminaemiaMetabolism and nutrition disorders	12/84	6/81
BradycardiaCardiac disorders	4/84	9/81
Metabolic alkalosisMetabolism and nutrition disorders	5/84	9/81
Oxygen saturation decreasedInvestigations	9/84	6/81
TachypnoeaRespiratory, thoracic and mediastinal disorders	4/84	7/81
PneumoniaInfections and infestations	7/84	2/81

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Lucinactant	Sham Air	Total
<=18 years	84	81	165
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Age Continuous
Age Continuous(years)	Lucinactant	Sham Air	Total
Mean	0.44 ± 0.43	0.45 ± 0.43	0.45 ± 0.43

Sex: Female, Male
Sex: Female, Male(Participants)	Lucinactant	Sham Air	Total
Female	29	27	56
Male	55	54	109

Region of Enrollment
Region of Enrollment(participants)	Lucinactant	Sham Air	Total
United States	28	27	55
Chile	56	54	110

Study locations

3 sites

Call for information
Warrington, Pennsylvania 18976, United States
Call for Information
Concepcion, Chile
Call For Information
Santiago, Chile

References and documents

Publications

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. PubMed 22791092 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00578734
Lead sponsor: Windtree Therapeutics
Responsible party: Sponsor
First posted: Dec 21, 2007
Start date: Jun 2007
Primary completion: Apr 2010
Completion: Apr 2010
Results posted: Apr 27, 2012
Last update: May 3, 2012

Study contacts

Neal Thomas, MD

principal investigator · Milton S. Hershey Medical Center

Adrienne Randolph, MD

principal investigator · Boston Children's Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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