Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060487) titled '"Clinical significance of non-contact vital signs monitoring in children
with eating disorders: an exploratory prospective study"' on Feb. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Department of Pediatrics, National Hospital Organization Mie National Hospital
Condition:
Condition - eating disorder(anorexia nervosa,avoidant/restrictive food intake disorder)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - "The purpose of this study is to evaluate the relationship between changes in thyroid hormone levels (FT3) and changes in physical changes (weight, heart rate) measured by non-contact vital signs monitoring during the course from the start of renutrition through hospitalization to discharge in 10 children with anorexia nervosa and avoidant/restrictive food intake disorder.
Comparisons will be made with pediatric inpatients without eating disorders (control group of 10)."
Basic objectives2 - Others
Eligibility:
Age-lower limit - 6
years-old
Gender - Male and Female
Key inclusion criteria - (1)Patients who exhibited poor weight gain or weight loss during a defined period prior to admission.
(2)Patients who were able to communicate with medical staff (e.g., physicians and nurses) and deemed capable of continuing inpatient treatment.
(3) Patients for whom parental consent was obtained and whose own intent could be confirmed."
Key exclusion criteria - (1) Patients aged 6 to 17 years (corresponding to Japanese elementary school grade 1 through high school grade 3) diagnosed with anorexia nervosa or avoidant/restrictive food intake disorder, who did not exhibit poor weight gain or weight loss due to prior inpatient or outpatient treatment.
(2)Patients deemed unsuitable for participation in this study by the principal investigator."
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 18 Day
Anticipated trial start date - 2026 Year 01 Month 28 Day
Last follow-up date - 2028 Year 06 Month 18 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069196
Disclaimer: Curated by HT Syndication.