NCT00133614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2001

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2005

Completed
Last Updated

October 31, 2005

Status Verified

August 1, 2005

First QC Date

August 19, 2005

Last Update Submit

October 28, 2005

Conditions

Acute Lung Injury

Outcome Measures

Primary Outcomes (1)

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

Interventions

Prone PositioningPROCEDURE

Eligibility Criteria

Age2 Weeks - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)

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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Hospital, Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 16014597RESULT

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Martha Curley, RN,PhD,FAAN

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 23, 2005

Study Start

August 1, 2001

Study Completion

April 1, 2004

Last Updated

October 31, 2005

Record last verified: 2005-08

Locations

US(1)