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Prone Positioning in Pediatric Acute Lung Injury

Primary Purpose

Acute Lung Injury

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Prone Positioning
Sponsored by
National Institute of Nursing Research (NINR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury

Eligibility Criteria

2 Weeks - 18 Years (Child, Adult)All Sexes

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

Sites / Locations

  • Childrens Hospital, Boston

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 19, 2005
Last Updated
October 28, 2005
Sponsor
National Institute of Nursing Research (NINR)
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00133614
Brief Title
Prone Positioning in Pediatric Acute Lung Injury
Official Title
Prone Positioning in Pediatric Acute Lung Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Nursing Research (NINR)
Collaborators
National Institutes of Health (NIH)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Prone Positioning
Primary Outcome Measure Information:
Title
Prone positioning versus supine positioning in determining ventilator-free days in infants and children

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Curley, RN,PhD,FAAN
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital, Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16014597
Citation
Curley MA, Hibberd PL, Fineman LD, Wypij D, Shih MC, Thompson JE, Grant MJ, Barr FE, Cvijanovich NZ, Sorce L, Luckett PM, Matthay MA, Arnold JH. Effect of prone positioning on clinical outcomes in children with acute lung injury: a randomized controlled trial. JAMA. 2005 Jul 13;294(2):229-37. doi: 10.1001/jama.294.2.229.
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Prone Positioning in Pediatric Acute Lung Injury

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