Phase 3
Completed N=43
CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients
Source: ClinicalTrials.gov NCT00999713 ↗Enrolled (actual)
43
Serious AEs
51.2%
Results posted
Mar 2018
Primary outcomePrimary: All-cause Mortality at the Time of Pediatric Intensive Care Unit (PICU) Discharge — 15; 6 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality at the Time of Pediatric Intensive Care Unit (PICU) Discharge |
15; 6 | — |
| SECONDARY Ventilator Free Days (VFDs) |
0; 5.40 | — |
| SECONDARY Total Duration of Stay Required |
15.5; 21; 34.5; 65 | — |
| SECONDARY Change in Oxygenation: First Intervention |
18.30178397; 20.59720208; 16.10723481; 19.25708144; 14.79254257; 16.80523147 | — |
| SECONDARY Change in Oxygenation: Second Intervention |
15.65261779; 15.05105738; 21.28116857; 14.68059885; 17.47108142; 15.40251337 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must meet criteria for acute lung injury
- Intubated, mechanically ventilated, with respiratory failure secondary to diffuse, bilateral parenchymal lung disease (as judged by chest x-ray).
- Oxygenation index (OI) > 13, but 15 mmHg, or uncorrected congenital heart disease.
- Glasgow Coma Score 150/minute, or persistent bradyarrythmia - 10 milliequivalent (mEq)/L for more than 2 hours,
- persistent arterial oxygen desaturation, arterial partial pressure of oxygen (PaO2) 6.5 plus widening of QRS complex on EKG (QRS complex corresponds to the depolarization of the right and left ventricles of the heart).
Data sourced from ClinicalTrials.gov (NCT00999713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.