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Prone Positioning in Pediatric Acute Lung Injury

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ClinicalTrials.gov Identifier: NCT00133614
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : October 31, 2005
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
National Institute of Nursing Research (NINR)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Lung Injury Procedure: Prone Positioning Phase 3

Detailed Description:

Multicenter, randomized, controlled clinical trial conducted from August 28, 2001 to April 23, 2004, of 102 pediatric patients from 7 US pediatric intensive care units aged 2 weeks to 18 years who were treated with supine vs. prone positioning. Randomization was concealed and group assignment was not blinded.

Patients were randomized to either supine or prone positioning within 48 hours of meeting acute lung injury criteria, with those patients in the prone group being positioned within 4 hours of randomization and remaining prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days, after which they were positioned supine. Both groups were treated using lung protective ventilator and sedation protocols, extubation readiness testing, and hemodynamic, nutrition, and skin care guidelines.


Study Type : Interventional  (Clinical Trial)
Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prone Positioning in Pediatric Acute Lung Injury
Study Start Date : August 2001
Study Completion Date : April 2004





Primary Outcome Measures :
  1. Prone positioning versus supine positioning in determining ventilator-free days in infants and children


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133614


Locations
United States, Massachusetts
Childrens Hospital, Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Martha Curley, RN,PhD,FAAN Boston Children’s Hospital

Publications of Results:
ClinicalTrials.gov Identifier: NCT00133614     History of Changes
Other Study ID Numbers: 5336
5R01NR005336-04 ( U.S. NIH Grant/Contract )
First Posted: August 23, 2005    Key Record Dates
Last Update Posted: October 31, 2005
Last Verified: August 2005

Additional relevant MeSH terms:
Wounds and Injuries
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Respiration Disorders