Prone Positioning in Pediatric Acute Lung Injury
Completed · Phase 3
Conditions studied: Acute Lung Injury
In brief
The purpose of this trial is to test the hypothesis that at the end of 28 days, infants and children with acute lung injury treated with prone positioning would have more ventilator-free days than those treated with supine positioning.
Key facts
- Study ID
- NCT00133614
- Run by
- National Institute of Nursing Research (NINR)
- People needed
- 102
- Starts
- 2001-08-01
- Expected to finish
- 2004-04-01
- Last updated by the study team
- 2005-10-31
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >42 weeks post-conceptual age and <18 years of age
- On mechanical ventilation (defined as presence of an endotracheal/tracheostomy tube and currently using ventilator support)
- All of the following in the same 48 hour period:
- acute pulmonary parenchymal disease (i.e., chest radiograph report of diffuse bilateral pulmonary alveolar infiltrates)
- mechanical ventilation for at least 1 hour and anticipated need to continue mechanical ventilation for at least 24 hours
- at least one PaO2/FiO2 ratio <300 (adjusted for barometric pressure: if altitude > 1000m, then PaO2/FiO2 <= 300x(B.P./760), regardless of mean airway pressure)
- functional arterial catheter for blood gas analysis
You may not qualify if…
- Persistent hypotension (defined as systolic blood pressure of 70mmHg+(2x age in years)); i.e. patients requiring either intravenous fluids and/or increases of additional cardiotonic medications every 2 hours
- Active bleeding that requires ongoing blood/fluid volume replacement
- Currently on extracorporeal membrane oxygenation (ECMO)
- Severe chronic lung disease (cystic fibrosis or bronchopulmonary dysplasia)
- Respiratory failure presumed to be the result of cardiac disease
- History of symptomatic or uncorrected congenital heart disease or a right to left intracardiac shunt
- Bone marrow or lung transplant
- Current known diagnosis of any of the following:
- upper airway disease (i.e., tracheitis, tracheomalacia)
- reactive airway disease (receiving beta agonists or acute doses of systemic corticosteroids)
- refractory cerebral hypertension (intracranial pressure [ICP] >20mmHg for 1 hr)
- neuromuscular respiratory failure (chronic assisted ventilation)
- spinal instability (uncleared cervical spine)
- unstable long bone fractures
- Nonpulmonary condition that may be exacerbated by the prone position (for example, osteogenesis imperfecta, craniofacial surgery in the past week)
- Draining abdominal surgical wound
- Pregnancy
- Subject's family/medical team have decided not to provide full support (patient treatment considered futile)
- Enrollment in any other clinical trial within the last 30 days
Where it is running
- Childrens Hospital, Boston — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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