OncologyPEWSPALNCT04180306
PEWS Implementation in an LMIC Setting
A study testing pediatric early warning scoring system and resuscitation curriculum in people with Oncology, run by Boston Children's Hospital at 2 sites in Palestinian Territories.
Trial summary
The PEWS implementation study will be undertaken with the following objectives: 1. Assess the effectiveness of implementation of PEWS and resuscitation training to identify patients at risk for clinical deterioration and to impact the frequency of clinical interventions made by treating providers on these patients. 2. Read more about this study
- Who is it for?
- Ages 0 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Oncology
- What is being tested?
- pediatric early warning scoring system and resuscitation curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,850 participants
- Where
- 2 sitesPalestinian Territories
- Study dates
- 1 Sep 2019to 30 Sep 2023
- Phase
- Interventional
- 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 0 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients eligible for the study are defined as pediatric patients (between birth and 12 years of age) admitted and subsequently discharged from the pediatric oncology ward in Beit Jala, Palestine and Gaza City, Palestine between March 2019 to June 2020
Who cannot join
- Patients will be excluded if they are not admitted to inpatient status. No oncology outpatients such as those in the infusion program will be included.
Trial locations and contacts
2 sites in 1 country.
Palestinian Territories2 sites
Beit Jala Hospital
Bethlehem
Rantisi Hospital
Gaza
About this study
Official title: Implementation of Pediatric Early Warning Scores and a Context-adapted Resuscitation Training Course to Improve Outcomes in an LMIC Pediatric Inpatient Oncology Ward
The PEWS implementation study will be undertaken with the following objectives:
- Assess the effectiveness of implementation of PEWS and resuscitation training to identify patients at risk for clinical deterioration and to impact the frequency of clinical interventions made by treating providers on these patients.
- Assess the effectiveness of implementation of PEWS and resuscitation training to impact time sensitive clinical interventions made on patients at risk for clinical deterioration.
- Assess the impact of implementation of PEWS and resuscitation training on length of stay for patients admitted to the pediatric oncology ward.
- Conditions
- Oncology
- Being tested
- pediatric early warning scoring system and resuscitation curriculum
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pediatric early warning scoring system and resuscitation curriculumOther
teaching resuscitation to medical providers and implementing a scoring tool to help identify patients at risk for clinical deterioration in an inpatient setting
| Study group | Role | What they receive |
|---|---|---|
| Inpatient pediatric oncology patients | Other | All patients admitted to the pediatric oncology ward will be in the cohort Receives: Other: pediatric early warning scoring system and resuscitation curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elevated Pediatric Early Warning Score (PEWS)
frequency of patients whose PEWS score indicates 'risk for clinical deterioration' and receive a clinical intervention. PEWS 3 or greater (Scale is PEWS 0-6) is defined as at risk for clinical deterioration with a higher score concerning for worse clinical outcome.
Measured: 1 year
Secondary outcomes (4)
Time to antibiotics
Time to antibiotics defined as time from documented vital signs/PEWS to time of antibiotic administration measured in minutes
Measured: 1 year
Time to IV fluid bolus
Time to fluids defined as time from documented vital signs/PEWS to time of documented IV fluid bolus measured in minutes
Measured: 1 year
Volume of IV fluids
Volume of fluids received defined as volume given up to 60 minutes after the initiation of the first fluid bolus measured in milliliters
Measured: 1 year
Length of stay
Length of stay for all patients admitted to the inpatient ward
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start1 Sep 2019
- Primary completion31 Oct 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Niescierenko, Boston Children's Hospital
- Investigators
- Michelle Niescierenko, MD MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180306
- Sponsor's protocol ID
- PEWSpalestine
- Acronym
- PEWSPAL
- Status last verified
- Jan 2024
- First submitted
- 23 Nov 2019
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Pediatric Early Warning Scores and a Context-adapted Resuscitation Training Course to Improve Outcomes in an LMIC Pediatric Inpatient Oncology Ward
- ClinicalTrials.gov ID
- NCT04180306
- Acronym / sponsor ID
- PEWSPAL / PEWSpalestine
- Conditions
- Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,850 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 27 Nov 2019 (actual)
- 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 PEWS implementation study will be undertaken with the following objectives:
- Assess the effectiveness of implementation of PEWS and resuscitation training to identify patients at risk for clinical deterioration and to impact the frequency of clinical interventions made by treating providers on these patients.
- Assess the effectiveness of implementation of PEWS and resuscitation training to impact time sensitive clinical interventions made on patients at risk for clinical deterioration.
- Assess the impact of implementation of PEWS and resuscitation training on length of stay for patients admitted to the pediatric oncology ward.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatient pediatric oncology patients | Other | Other: pediatric early warning scoring system and resuscitation curriculumAll patients admitted to the pediatric oncology ward will be in the cohort |
Who may qualify
- Ages
- 0 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients eligible for the study are defined as pediatric patients (between birth and 12 years of age) admitted and subsequently discharged from the pediatric oncology ward in Beit Jala, Palestine and Gaza City, Palestine between March 2019 to June 2020
Key exclusion criteria (1 listed)
- Patients will be excluded if they are not admitted to inpatient status. No oncology outpatients such as those in the infusion program will be included.
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 |
|---|---|---|
| pediatric early warning scoring system and resuscitation curriculumteaching resuscitation to medical providers and implementing a scoring tool to help identify patients at risk for clinical deterioration in an inpatient setting | Other | Inpatient pediatric oncology patients |
Primary outcome
Elevated Pediatric Early Warning Score (PEWS)
Time frame: 1 year
frequency of patients whose PEWS score indicates 'risk for clinical deterioration' and receive a clinical intervention. PEWS 3 or greater (Scale is PEWS 0-6) is defined as at risk for clinical deterioration with a higher score concerning for worse clinical outcome.
4 secondary outcomes
Time to antibiotics
Time frame: 1 year
Time to IV fluid bolus
Time frame: 1 year
Volume of IV fluids
Time frame: 1 year
Length of stay
Time frame: 1 year
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 10 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Michelle Niescierenko, MD MPH principal investigator
Boston Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pediatric early warning scoring system and resuscitation curriculum in people with Oncology, run by Boston Children's Hospital at 2 sites in Palestinian Territories.
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 1 inclusion and 1 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 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Palestinian Territories. 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.
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?
Elevated Pediatric Early Warning Score (PEWS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2024.