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NCT00999713 · ClinicalTrials.gov registry record · Phase 2
CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients
A Phase 2 study of Acute Lung Injury, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 16
- Study locations
NCT00999713: Completed Phase 2 study of Acute Lung Injury, sponsored by Milton S. Hershey Medical Center.
NCT00999713 is a Phase 2 study of Acute Lung Injury that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 43 participants, below the 122-participant average among 10 other Acute Lung Injury trials with a reported enrollment target (65% lower). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00999713, a Phase 2 study of Acute Lung Injury, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 16
- Study locations
Study Summary
Acute lung injury (ALI) is a common, life-threatening complication among pediatric leukemia and lymphoma and hematopoietic stem cell transplant (HSCT) recipients. Although these children represent a relatively small and unique patient population, they account for the largest proportion of deaths of all pediatric diseases. The long-term goal of this project is to improve outcomes among these patients. Recently, the intratracheal administration of calfactant has resulted in decreased mortality among children with ALI including promising results among children with cancer and following HSCT. Consequently, the primary specific aim of this study is to assess the effect of calfactant on intensive care (PICU) survival among pediatric leukemia and lymphoma and HSCT patients with ALI. Secondary aims include assessment of the effect of calfactant on oxygenation and on the length of mechanical ventilation, PICU stay, and hospital stay. Calfactant therapy has been found to be of benefit in acute lung injury in the overall pediatric population by improving oxygenation and decreasing mortality. These findings, in conjunction with recent subgroup analysis in which calfactant therapy appeared to improve outcomes in immunocompromised children provide the rationale for assessing calfactant therapy in this patient population. Funding Source - FDA Office of Orphan Products Development (OOPD)
Primary Outcome
Overall mortality rate from admission to PICU discharge
Conditions Studied
Interventions
- DRUG Calfactant
- OTHER Air placebo
Study Locations (16)
Pennsylvania
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center - Hershey
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh - Pittsburgh
California
- Children's Hospital of Los Angeles - Los Angeles
- University of California San Francisco - San Francisco
New York
- Weill Cornell Medical Center - New York
- Maria Fareri Children's Hospital - Valhalla
Ohio
- Rainbow Babies Hospital - Cleveland
- Nationwide Children's Hospital - Columbus
Arizona
- Phoenix Children's Hospital - Phoenix
Indiana
- Riley Children's Hospital - Indianapolis
New Jersey
- Hackensack University Medical Center - Hackensack
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2010-06 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
What the finished NCT00999713 record still lists
NCT00999713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 122-participant average among 10 other Acute Lung Injury trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Acute Lung Injury appearing as the primary indexed condition, and to 2 interventions - of which Calfactant is the first listed.
NCT00999713 lists 16 locations in 11 states (Pennsylvania, California, New York).
Frequently Asked Questions
What is clinical trial NCT00999713 about?
NCT00999713 is a clinical study titled "CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients". Acute lung injury (ALI) is a common, life-threatening complication among pediatric leukemia and lymphoma and hematopoietic stem cell transplant (HSCT) recipients. Although these children represent a relatively small and unique patient population, they account for the largest proportion of deaths of ...
What is the current status of trial NCT00999713?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2010-06. Estimated completion is 2015-10.
What conditions does trial NCT00999713 study?
This clinical trial studies the following conditions: Acute Lung Injury.
What interventions are being tested in trial NCT00999713?
The interventions under investigation include: Calfactant (DRUG), Air placebo (OTHER).
Who is sponsoring clinical trial NCT00999713?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00999713 being conducted?
This trial has 16 study locations across Arizona, California, Indiana, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00999713's enrollment target sits among peer trials
43 7th of 10 higher than 4 of 10 other Acute Lung Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lung Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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