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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 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.
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)
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00999713
The ClinicalTrials.gov registry entry for NCT00999713 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 122-participant average among 10 other Acute Lung Injury trials with a reported enrollment target (65% lower). The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
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 reports 16 study locations spanning 11 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.