A Phase 3 Trial of Calfactant for ALI in Pediatric Leukemia and HSCT Patients

Inclusion Criteria:

1. 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 < 37, for two consecutive blood gases which
should be separated by at least one hour within 48 hours of the initiation of
mechanical ventilation.

- Arterial catheter placement

- Parental informed consent

2. Patients must have a diagnosis of leukemia/lymphoma undergoing active treatment or
following HSCT for any indication. Leukemia/lymphoma will be defined according to the
National Cancer Institute Surveillance Epidemiology and End Results Collaborative
Staging Manual including those conditions defined as borderline such as
myelodysplastic syndromes. All forms of HSCT will be eligible, allogeneic as well as
autologous.

Exclusion Criteria:

1. Clinical diagnosis of congestive heart failure and/or pulmonary capillary wedge
pressure >15 mmHg, or uncorrected congenital heart disease.

2. Glasgow Coma Score < 8 (prior to respiratory failure).

3. Pre-existing limitations on care options, (Do Not Attempt Resuscitation Orders, etc).

4. Patients with impending death from another disease.

5. Patients moribund or with other organ failure at possible randomization:

- hypotension unresponsive to treatment (mean BP < 60 or < 5th % for age),

- persistent cardiac tachyarrhythmia >150/minute, or persistent bradyarrythmia <
50/minute, or age appropriate criteria for younger children,

- metabolic acidosis > - 10 mEq/L for more than 2 hours,

- persistent arterial oxygen desaturation, PaO2 < 50 or SaO2saturation < 80%,

- hyperkalemia, serum K+ > 6.5 plus widening of QRS complex on EKG