CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients
Public ClinicalTrials.gov record NCT00999713. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Trial of Calfactant for ALI in Pediatric Leukemia and HSCT Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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)
Study identification
- NCT ID
- NCT00999713
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 43 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Months to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2010 (Type not available)
- Primary completion
- Sep 2015 (Actual)
- Completion
- Oct 2015 (Actual)
- Last update posted
- Mar 16, 2018
2010 – 2015
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | — | — |
| Children's Hospital of Los Angeles | Los Angeles | California | — | — |
| University of California San Francisco | San Francisco | California | — | — |
| Riley Children's Hospital | Indianapolis | Indiana | — | — |
| Hackensack University Medical Center | Hackensack | New Jersey | — | — |
| Weill Cornell Medical Center | New York | New York | — | — |
| Maria Fareri Children's Hospital | Valhalla | New York | — | — |
| Rainbow Babies Hospital | Cleveland | Ohio | — | — |
| Nationwide Children's Hospital | Columbus | Ohio | — | — |
| Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17078 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | — | — |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | — | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | — | — |
| Texas Children's Hospital | Houston | Texas | — | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00999713, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 16, 2018 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00999713 live on ClinicalTrials.gov.