Feasibility and Safety of Acupuncture With Semi-Permanent Needles for the Prevention of Irinotecan-Associated Diarrhea in Pediatric Solid Tumors
NCT05507736
Diarrhea, Neoplasms
Esplugues de Llobregat, Barcelona, Spain
View Trial DetailsNCT Number: NCT04581655
The study will describe characteristics of pediatric cancer patients admitted to Italian PICUs and will analyze risk factors of PICU admission, neurological outcome, and mortality. After a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months gathering data from 15-20 Italian PICUs.
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Notify MeUp to 18 year
All sexes
Observational
Salesi Hospital, Ancona, Italy
The study aim to evaluate:
Inclusion criteria
age <= 18 years, informed consent. Exclusion criteria: informed consent not obtained. After a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months (March 2021 - February 2021) gathering data from 15-20 Italian PICUs. Each Center can decide whether to participate only in the prospective phase. Data will be recorded in an electronic data collection form in Red Cap.
The following variables will be collected:
Considering the participation of 15-20 centers involving 20 patients in a year, the expected number is 600 patients considering the retrospective phase (optional, therefore some Centers may not contribute) and the prospective phase.
Study sites will also take part to a survey designed to collect data in order to describe Italian PICUs involved in providing care to cancer patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: from date of patient's admission in PICU to date of PICU discharge assessed up to 7 days
rate of dead patients
Time frame: from discharge to 30th day after PICU discharge
30-days mortality
Time frame: from 31st to 90th day after PICU discharge
90-days mortality
Time frame: on date of PICU discharge assessed up to 10 days
patients's Pediatric Overall Performance Category (POPC) score (a 6 level score: 4 to 6 is considered bad outcome)
Azienda Ospedaliera di Padova
Other
Retrospective and Prospective Analysis of Risk and Outcome Factors in Oncohematological Patients Admitted to Italian Pediatric Intensive Care Units: a Multicenter Study
Acronym: ONCOTIPNET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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