Nutritional Care After Discharge in Children Term Born-18years Old
NCT ID: NCT06414200
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
260 participants
INTERVENTIONAL
2024-12-01
2027-03-31
Brief Summary
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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
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Detailed Description
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Intervention group The intervention consists of a tailored nutritional follow-up plan, including a parent empowerment program, made by a multidisciplinary support team (primarily responsible clinician, dietician, psychologist and, if indicated, a speech therapist). At discharge and follow-up at 6, 12 and 18 weeks after discharge, food diaries (including growth) and questionnaires\* relating to feeding behaviour and parental stress are filled out by parents/caregivers.
One week before the planned outpatient visit of the patient and their parents, questionnaires will be sent with preferred software available in ErasmusMC ICT infrastructure through e-mail. The findings gathered from these nutritional data and questionnaires will be visualized on a dashboard (visible to parents and the caregivers) to discuss and help resolve the most relevant problems with the parents during the follow-up moments. During the outpatient visit, the growth and body composition of the child will also be assessed.
The nutritional support team will discuss the outcomes of the questionnaires and make tailored advice based on the problems parents have reported. The dietician will discuss this tailored advice with the children and/or parents based on the growth, the nutritional intake of the child, and the problems parents have reported regarding the feeding behaviour of the child and their parental distress. Subsequently, the dietician will provide recommendations and psychoeducation to parents and/or patients in order to improve the nutritional status.
At 6 months after discharge follow/up measurements such as, growth, duration and frequency of nutritional support, food diary, feeding behaviour of the child, QoL of the child, parental stress and QoL will be gathered.
Evaluation and treatment other than follow-up at 6, 8 and 12 weeks after discharge with one of the health care professionals are on indication and data will not be collected.
The intervention differs from the usual care, because follow-up is at standard time periods. In the usual care this is not regulated. Nutritional support is given in a multidisciplinary team including a psychologist, but in the pilot study we saw collaboration with the pediatrician and speech therapist only. In the intervention we also focuses on parenteral stress, which is new and different from usual care.
Usual care group Nutritional advice in the usual care group will be given after discharge and follow-up according to standard practices. At 6 months after discharge an evaluation will be done equal to the intervention group. To collect information about the number of readmissions to the hospital and reason of admission, visits to a health-care provider, and growth parameters parents are asked to fill in a logbook to collect this data between discharge and 6 months follow-up. This method has been chosen because these are parameters that are difficult to remember at the visit 6 months after discharge.
\*The following age-adjusted and validated questionnaires will be used to assess emotional functioning, the pediatric feeding disorders, and parenteral stress:
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Control group/usual care group
The usual care as given at that moment in that hospital. The group to compare the intervention with.
No interventions assigned to this group
Intervention group
The intervention consists of a tailored nutritional follow-up plan, including a parent empowerment program, made by a multidisciplinary support team (primarily responsible clinician, dietician, psychologist and, if indicated, a speech therapist). At discharge and follow-up at 6, 12 and 18 weeks after discharge, food diaries (including growth) and questionnaires\* relating to feeding behaviour and parental stress are filled out by parents/caregivers.
multidisciplinary structured tailored made nutritional advice
The goal is a structured follow-up after discharge. Parents need to fill in questionnaires about eating behavior en feeding difficulties about their child. They also need to fill in a questionnaire about their stress. Together with their nutritional intake (3-days food diary) and growth a tailor-made nutritional plan is made. All the information I showed in a dashboard and discussed it with their dietitian. Who discusses this information in a multi-disciplinary team (pediatrician, psychologist and if needed a speech therapist).
Interventions
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multidisciplinary structured tailored made nutritional advice
The goal is a structured follow-up after discharge. Parents need to fill in questionnaires about eating behavior en feeding difficulties about their child. They also need to fill in a questionnaire about their stress. Together with their nutritional intake (3-days food diary) and growth a tailor-made nutritional plan is made. All the information I showed in a dashboard and discussed it with their dietitian. Who discusses this information in a multi-disciplinary team (pediatrician, psychologist and if needed a speech therapist).
Eligibility Criteria
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Inclusion Criteria
* Admitted with newly initiated nutritional support(oral and/or enteral nutritional support) during hospitalization
* Nutritional Support continues at home after discharge.
Exclusion Criteria
* Children in need of parenteral nutrition at discharge
* Children with DSM-5 diagnosed feeding disorders such as anorexia
* Absence of written informed consent
7 Days
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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S.C.A.T Verbruggen
Principal Investigator
Principal Investigators
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Sascha C Verbruggen
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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ErasmusMC
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL84484.078.23
Identifier Type: -
Identifier Source: org_study_id
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