Pediatric Acute Neurologic Disease, Traumatic and Non-traumaticPhase 2NCT02209935
RCT: Early Rehabilitation Protocol vs. Usual Care in the Pediatric ICU for Children With Acute Brain Injury
A Phase 2 study testing Early Rehabilitation Protocol in people with Pediatric Acute Neurologic Disease, Traumatic and Non-traumatic, run by University of Pittsburgh at 3 sites in United States.
Trial summary
Background. Early rehabilitation programs (ERP) that include physical, occupational, and speech therapies lessens debilitation and promotes return to previous physical and cognitive functioning and have been successfully applied in adult intensive care units (ICUs). Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Pediatric Acute Neurologic Disease, Traumatic and Non-traumatic
- What is being tested?
- Early Rehabilitation Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2015to 31 Aug 2017
- Phase
- Phase 2
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3-17 years
- ABI due to TBI, ischemia, CNS infection / inflammation (i.e., meningitis, encephalitis), or cardiac arrest
- Subjects will be enrolled prior to 48 hours of PICU admission, have English or Spanish speaking parents/guardians, and en expected ICU stay ≥ 3 days
Who cannot join
- Children with a do not resuscitate status
- Pediatric Cerebral Performance Category (PCPC) score 4-5 (4=severe disability and 5=persistent vegetative state) prior to ABI or are not expected to survive > 24 hours will be excluded
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: RCT Early Rehabilitation Protocol vs. Usual Care in the Pediatric ICU for Children With Acute Brain Injury
Background. Early rehabilitation programs (ERP) that include physical, occupational, and speech therapies lessens debilitation and promotes return to previous physical and cognitive functioning and have been successfully applied in adult intensive care units (ICUs). Despite the fact that critically ill children with acute brain injury (ABI) are at increased risk of life-long disability and stunted development, benefits of ERP for this group have not been studied and are not standard of care in pediatric ICUs.
Objectives. The aims of this study are 1) To better understand current practices and barriers to use of these therapies and 2) To subsequently evaluate ERP vs. usual care in children with ABI in the ICU by randomizing children to these groups and measuring outcomes. We expect that ERP therapies are underutilized in the PICU and that outcomes in the ERP group will be superior compared to the usual care group.
Read more
Methods. The first task of this research program is to survey healthcare professionals (physicians, nurses, allied health) and families of children in the ICU about their hospital's resources, current practices, and barriers to ERP. This survey will be distributed to the 78 sites affiliated with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI), a group of clinicians and researchers dedicated to improving child outcomes from critical illness. Next, we will enroll 175 children with ABI in a randomized, controlled trial of ERP versus usual care. Children enrolled in ERP will begin therapies by 48 hours of ICU admission and those in the usual care group will begin therapies when these services are ordered by treating physicians. Children aged 3-17 years with ABI expected to be admitted to the ICU > 48 hours due to trauma, infection, low oxygen, or low blood flow to the brain are eligible. Therapy interventions are individualized for the child's clinical status. The effectiveness of ERP will be measured using the Vineland Behavior Adaptive Scale (VABS) pre-ABI and 6 months post-ABI. This test, validated for children, assesses a child's physical and cognitive function as well as behavior. Other tests will be performed that assesses child and family quality of life and length of hospital admission. Our outcome tests were chosen because 1) They are the most important outcomes to families of children as surveyed in our ICU and 2) They are outcomes that can be influenced by ERP.
Summary. This is the first and largest study designed to evaluate whether ERP improves outcomes for critically ill children with ABI. We anticipate that rehabilitation practices in ICUs will be unprotocolized and under-utilized. We expect that patients in the ERP group will have superior adaptive and quality of life outcomes, outcomes important to families, without increasing adverse events compared to patients in the usual care group.
- Being tested
- Early Rehabilitation Protocol, Usual care
- Keywords
- pediatric, acute neurologic disease, critical care, rehabilitation, outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Rehabilitation ProtocolOther
Usual careOther
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Typically, usual care is when therapies are not initiated until the treating team places an order for each element of care (physical, occupational, speech, and emotional therapy consultation). Receives: Other: Usual care |
| Early Rehabilitation Protocol | Experimental | Physical, occupational, speech, and emotional evaluation and support personalized to the subject's severity of illness and developmental status. Receives: Other: Early Rehabilitation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vineland Adaptive Behavioral Scale score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startFeb 2015
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric Acute Neurologic Disease, Traumatic and Non-traumaticStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Ericka Fink, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209935
- Sponsor's protocol ID
- PCORI APDTO
- Status last verified
- Sep 2017
- First submitted
- 4 Aug 2014
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Piva TC, Ferrari RS, Schaan CW. Early mobilization protocols for critically ill pediatric patients: systematic review. Rev Bras Ter Intensiva. 2019 Jun 10;31(2):248-257. doi: 10.5935/0103-507X.20190038.
PubMed 31215603Treble-Barna A, Beers SR, Houtrow AJ, Ortiz-Aguayo R, Valenta C, Stanger M, Chrisman M, Orringer M, Smith CM, Pollon D, Duffett M, Choong K, Watson RS, Kochanek PM, Fink EL; PICU-Rehabilitation Study Group, Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, and Prevalence of Acute critical Neurological disease in children: A Global Epidemiological Assessment (PANGEA) Investigators. PICU-Based Rehabilitation and Outcomes Assessment: A Survey of Pediatric Critical Care Physicians. Pediatr Crit Care Med. 2019 Jun;20(6):e274-e282. doi: 10.1097/PCC.0000000000001940.
PubMed 30946294Fink EL, Beers SR, Houtrow AJ, Richichi R, Burns C, Doughty L, Ortiz-Aguayo R, Madurski CA, Valenta C, Chrisman M, Golightly L, Kiger M, Patrick C, Treble-Barna A, Pollon D, Smith CM, Kochanek P; PICU-Rehabilitation Study Group. Early Protocolized Versus Usual Care Rehabilitation for Pediatric Neurocritical Care Patients: A Randomized Controlled Trial. Pediatr Crit Care Med. 2019 Jun;20(6):540-550. doi: 10.1097/PCC.0000000000001881.
PubMed 30707210
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Early Rehabilitation Protocol vs. Usual Care in the Pediatric ICU for Children With Acute Brain Injury
- ClinicalTrials.gov ID
- NCT02209935
- Acronym / sponsor ID
- PCORI APDTO
- Keywords
- pediatric, acute neurologic disease, critical care, rehabilitation, outcome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Feb 2015 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 6 Aug 2014 (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.
Background. Early rehabilitation programs (ERP) that include physical, occupational, and speech therapies lessens debilitation and promotes return to previous physical and cognitive functioning and have been successfully applied in adult intensive care units (ICUs). Despite the fact that critically ill children with acute brain injury (ABI) are at increased risk of life-long disability and stunted development, benefits of ERP for this group have not been studied and are not standard of care in pediatric ICUs.
Objectives. The aims of this study are 1) To better understand current practices and barriers to use of these therapies and 2) To subsequently evaluate ERP vs. usual care in children with ABI in the ICU by randomizing children to these groups and measuring outcomes. We expect that ERP therapies are underutilized in the PICU and that outcomes in the ERP group will be superior compared to the usual care group.
Methods. The first task of this research program is to survey healthcare professionals (physicians, nurses, allied health) and families of children in the ICU about their hospital's resources, current practices, and barriers to ERP. This survey will be distributed to the 78 sites affiliated with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI), a group of clinicians and researchers dedicated to improving child outcomes from critical illness. Next, we will enroll 175 children with ABI in a randomized, controlled trial of ERP versus usual care. Children enrolled in ERP will begin therapies by 48 hours of ICU admission and those in the usual care group will begin therapies when these services are ordered by treating physicians. Children aged 3-17 years with ABI expected to be admitted to the ICU > 48 hours due to trauma, infection, low oxygen, or low blood flow to the brain are eligible. Therapy interventions are individualized for the child's clinical status. The effectiveness of ERP will be measured using the Vineland Behavior Adaptive Scale (VABS) pre-ABI and 6 months post-ABI. This test, validated for children, assesses a child's physical and cognitive function as well as behavior. Other tests will be performed that assesses child and family quality of life and length of hospital admission. Our outcome tests were chosen because 1) They are the most important outcomes to families of children as surveyed in our ICU and 2) They are outcomes that can be influenced by ERP.
Summary. This is the first and largest study designed to evaluate whether ERP improves outcomes for critically ill children with ABI. We anticipate that rehabilitation practices in ICUs will be unprotocolized and under-utilized. We expect that patients in the ERP group will have superior adaptive and quality of life outcomes, outcomes important to families, without increasing adverse events compared to patients in the usual care group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual careTypically, usual care is when therapies are not initiated until the treating team places an order for each element of care (physical, occupational, speech, and emotional therapy consultation). |
| Early Rehabilitation Protocol | Experimental | Other: Early Rehabilitation ProtocolPhysical, occupational, speech, and emotional evaluation and support personalized to the subject's severity of illness and developmental status. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3-17 years
- ABI due to TBI, ischemia, CNS infection / inflammation (i.e., meningitis, encephalitis), or cardiac arrest
- Subjects will be enrolled prior to 48 hours of PICU admission, have English or Spanish speaking parents/guardians, and en expected ICU stay ≥ 3 days
Key exclusion criteria (2 listed)
- Children with a do not resuscitate status
- Pediatric Cerebral Performance Category (PCPC) score 4-5 (4=severe disability and 5=persistent vegetative state) prior to ABI or are not expected to survive > 24 hours will be excluded
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 |
|---|---|---|
| Early Rehabilitation Protocol | Other | Early Rehabilitation Protocol |
| Usual care | Other | Usual Care |
Primary outcome
Vineland Adaptive Behavioral Scale score
Time frame: 6 months
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 6 Sep 2017.
- Derived from this study: PubMed 31215603Piva TC, Ferrari RS, Schaan CW. Early mobilization protocols for critically ill pediatric patients: systematic review. Rev Bras Ter Intensiva. 2019 Jun 10;31(2):248-257. doi: 10.5935/0103-507X.20190038.
- Derived from this study: PubMed 30946294Treble-Barna A, Beers SR, Houtrow AJ, Ortiz-Aguayo R, Valenta C, Stanger M, Chrisman M, Orringer M, Smith CM, Pollon D, Duffett M, Choong K, Watson RS, Kochanek PM, Fink EL; PICU-Rehabilitation Study Group, Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, and Prevalence of Acute critical Neurological disease in children: A Global Epidemiological Assessment (PANGEA) Investigators. PICU-Based Rehabilitation and Outcomes Assessment: A Survey of Pediatric Critical Care Physicians. Pediatr Crit Care Med. 2019 Jun;20(6):e274-e282. doi: 10.1097/PCC.0000000000001940.
- Derived from this study: PubMed 30707210Fink EL, Beers SR, Houtrow AJ, Richichi R, Burns C, Doughty L, Ortiz-Aguayo R, Madurski CA, Valenta C, Chrisman M, Golightly L, Kiger M, Patrick C, Treble-Barna A, Pollon D, Smith CM, Kochanek P; PICU-Rehabilitation Study Group. Early Protocolized Versus Usual Care Rehabilitation for Pediatric Neurocritical Care Patients: A Randomized Controlled Trial. Pediatr Crit Care Med. 2019 Jun;20(6):540-550. doi: 10.1097/PCC.0000000000001881.
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Early Rehabilitation Protocol in people with Pediatric Acute Neurologic Disease, Traumatic and Non-traumatic, run by University of Pittsburgh at 3 sites 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 3 inclusion and 2 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 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Vineland Adaptive Behavioral Scale score (time frame: 6 months). 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 NCT02209935, which also lists 3 linked publications.
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 6 Sep 2017.