Prone Positioning in Pediatric Acute Lung Injury

October 28, 2005 updated by: National Institute of Nursing Research (NINR)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Childrens Hospital, Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Prone positioning versus supine positioning in determining ventilator-free days in infants and children

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Nursing Research (NINR)

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Martha Curley, RN,PhD,FAAN, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Completion

April 1, 2004

Study Registration Dates

First Submitted

August 19, 2005

First Submitted That Met QC Criteria

August 19, 2005

First Posted (Estimate)

August 23, 2005

Study Record Updates

Last Update Posted (Estimate)

October 30, 2005

Last Update Submitted That Met QC Criteria

October 28, 2005

Last Verified

August 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5336
  • 5R01NR005336-04 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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