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Prone Positioning in Pediatric Acute Lung Injury

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:
NCT00133614
First received: August 19, 2005
Last updated: October 28, 2005
Last verified: August 2005
History of Changes
  Purpose

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 Intervention Phase
Acute Lung Injury
 Procedure: Prone Positioning
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prone Positioning in Pediatric Acute Lung Injury

Further study details as provided by National Institute of Nursing Research (NINR):

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

Estimated Enrollment: 102
Study Start Date: August 2001
Estimated Study Completion Date: April 2004
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Children's Hospital Boston
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00133614     History of Changes
Other Study ID Numbers: 5336, 5R01NR005336-04
Study First Received: August 19, 2005
Last Updated: October 28, 2005
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on June 17, 2013