Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT04150120
Eligibility Criteria:
Inclusion Criteria (Intervention group):
Legal guardians of children below four years of age who are hospitalised for:
* reconstructive surgery for congenital malformations
* cardiac surgery for CHD
* premature birth
* paediatric cancer and in treatment
* are in need of nutritional supplements
* are about to be discharged from the hospital
* are able to communicate in the local language (Swedish in Sweden and Danish in Denmark)
* signs informed consent
Inclusion Criteria (Control group):
Legal guardians of children below four years of age who fulfil the intervention group inclusion criteria but:
* do not want to use the e-device
* not recruited for the intervention group
* are recruited after the stipulated numbers for the intervention group are met
Exclusion Criteria:
* Legal guardians of children fulfilling the inclusion criteria but where the child has complications or comorbidity which may affect the results of the study (as defined by the responsible medical physician)
* The legal guardian refuses to sign informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Days
Maximum Age:
47 Months
Study:
NCT04150120
Study Brief:
Protocol Section:
NCT04150120