Acute Lung InjuryPhase 3NCT00133614
Prone Positioning in Pediatric Acute Lung Injury
A Phase 3 study testing Prone Positioning in people with Acute Lung Injury, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 weeks to 18 years
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- Prone Positioning
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Apr 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 18 years
- All sexes
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Hospital, Boston
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Acute Lung Injury
- Being tested
- Prone Positioning
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone PositioningProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Prone positioning versus supine positioning in determining ventilator-free days in infants and children
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startAug 2001
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Martha Curley, RN,PhD,FAAN, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133614
- Sponsor's protocol ID
- 5336
- Other IDs
- 5R01NR005336-04
- Status last verified
- Aug 2005
- First submitted
- 19 Aug 2005
- Last updated
- 31 Oct 2005
- Results posted
- No
Publications
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.
PubMed 16014597
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Positioning in Pediatric Acute Lung Injury
- ClinicalTrials.gov ID
- NCT00133614
- Acronym / sponsor ID
- 5336
- Conditions
- Acute Lung Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2001
- Study completion
- Apr 2004
- First posted
- 23 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 weeks to 18 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone Positioning | Procedure or surgery | – |
Primary outcome
Prone positioning versus supine positioning in determining ventilator-free days in infants and children
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2005.
- Results publication: PubMed 16014597Curley 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Curley, RN,PhD,FAAN principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prone Positioning in people with Acute Lung Injury, run by National Institute of Nursing Research (NINR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prone positioning versus supine positioning in determining ventilator-free days in infants and children. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00133614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2005.