Cardio-Respiratory DistressNCT02958124
Early Mobilization: Evaluation of Feasibility and Security in Pediatric Intensive Care Unit
An observational study of Cardio-Respiratory Distress, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the feasibility and the security of early mobilization of infants in pediatric intensive care. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Cardio-Respiratory Distress
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2016to Jun 2017
- Phase
- Observational
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: All patients admitted in pediatric intensive care unit that respond to eligibility criteria
Who may be able to join
- cardiorespiratory stability
- between 24 and 48h post admission
Who cannot join
- Thorax open
- ECLS
- High frequency oscillatory ventilation
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, 1200
Damien Moerman, 00322764, damien.moerman@uclouvain.be
Pauline Bednarek, pauline.bednarek@student.uclouvain.be
About this study
The purpose of this study is to evaluate the feasibility and the security of early mobilization of infants in pediatric intensive care.
- Conditions
- Cardio-Respiratory Distress
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory parameters assessed by monitoring
cardiac frequency, respiratory frequency, blood pressure
Measured: up to 1 hour
Secondary outcomes (4)
EDIN scale (tool for assessing prolonged pain in preterm and newborns)
Measured: 5 minutes before mobilization
EDIN scale (tool for assessing prolonged pain in preterm and newborns)
Measured: up to 1 hour
COMFORT-BEHAVIOR scale (to measure the amount of stress of ventilated infants in a pediatric intensive care unit)
Measured: 5 minutes before mobilization
COMFORT-BEHAVIOR scale (to measure the amount of stress of ventilated infants in a pediatric intensive care unit)
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017 (estimated)
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 Cardio-Respiratory DistressStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958124
- Sponsor's protocol ID
- MobpediaSIP
- Status last verified
- Nov 2016
- First submitted
- 14 Sep 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
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 31215603
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilization: Evaluation of Feasibility and Security in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02958124
- Acronym / sponsor ID
- MobpediaSIP
- Conditions
- Cardio-Respiratory Distress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jun 2017 (estimated)
- First posted
- 8 Nov 2016 (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 study is to evaluate the feasibility and the security of early mobilization of infants in pediatric intensive care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients admitted in pediatric intensive care unit that respond to eligibility criteria
Key inclusion criteria (2 listed)
- cardiorespiratory stability
- between 24 and 48h post admission
Key exclusion criteria (3 listed)
- Thorax open
- ECLS
- High frequency oscillatory ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory parameters assessed by monitoring
Time frame: up to 1 hour
cardiac frequency, respiratory frequency, blood pressure
4 secondary outcomes
EDIN scale (tool for assessing prolonged pain in preterm and newborns)
Time frame: 5 minutes before mobilization
EDIN scale (tool for assessing prolonged pain in preterm and newborns)
Time frame: up to 1 hour
COMFORT-BEHAVIOR scale (to measure the amount of stress of ventilated infants in a pediatric intensive care unit)
Time frame: 5 minutes before mobilization
COMFORT-BEHAVIOR scale (to measure the amount of stress of ventilated infants in a pediatric intensive care unit)
Time frame: up to 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- 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.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardio-Respiratory Distress, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Nov 2016. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damien Moerman (003227642719, damien.moerman@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory parameters assessed by monitoring (time frame: up to 1 hour). 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 NCT02958124, 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 8 Nov 2016.