Nutritional Care After Discharge in Children Term Born-18years Old (NCT06414200) | Clinical Trial Compass
RecruitingNot Applicable
Nutritional Care After Discharge in Children Term Born-18years Old
Netherlands260 participantsStarted 2024-04-23
Plain-language summary
The goal of this stepped wedge cluster randomized trial is to compare nutritional care after discharge to an intervention in children term born - 18 years old discharged with newly initiated nutritional care.
The main question it aims to answer is:
To investigate whether a tailored nutritional care follow-up program in children who are being discharged from the hospital with nutritional support improves nutritional intake and status as well as feeding behavior and quality of life (QoL) in children and their parents. Furthermore, the effect on parental stress, anxiety, depression, and post-traumatic stress (PTSD) as well as QoL will be assessed with and without a tailored nutritional care follow-up program
Who can participate
Age range
7 Days – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children term born neonates till 18 years old
* Admitted with newly initiated nutritional support(oral and/or enteral nutritional support) during hospitalization
* Nutritional Support continues at home after discharge.
Exclusion Criteria:
* Children with existing nutritional support upon admission
* Children in need of parenteral nutrition at discharge
* Children with DSM-5 diagnosed feeding disorders such as anorexia
* Absence of written informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Weigth
Timeframe: From enrollment until 6 months after discharge
2
Height
Timeframe: From enrollment until 6 months after discharge
3
Head circumference
Timeframe: From enrollment until 6 months after discharge
4
Mid-upper arm circumference
Timeframe: From enrollment until 6 months after discharge
5
Length in children <2 years of age
Timeframe: From enrollment until 6 months after discharge