Clinical trial NCT06414200: Nutritional Care After Discharge in Children Term Born-18years Old
Official title: Nutritional Care After Hospital Discharge
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malnutrition, Child
Keywords: Nutritional care
After discharge
Pediatric
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 260
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multicentre study. It will be executed in an academic and five non-academic hospitals throughout The Netherlands. Due to the nature of the intervention, which involves changes to the provision of care and interaction between participants, there is a risk of cross-contamination within centers. Therefore, to avoid contamination of current practice, the stepped wedge cluster randomized controlled trial design was selected. This implies that all participating centers ('clusters') start with standard care (usual care). Subsequently, randomization will determine in which order the centers will begin with the NutriCAD intervention. In the end, all centers will have crossed over to be exposed to the NutriCAD intervention
Primary purpose: TREATMENT

Brief 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

Detailed description: All subjects, both in the usual care and intervention group, will be treated with the standard nutritional protocols of these individual hospitals during hospitalization. After hospital discharge, the treatments of the intervention and the control group will entail the procedures as described below.

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:

Eligibility criteria: 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

Primary outcomes:
measure: Weigth
timeFrame: From enrollment until 6 months after discharge
measure: Height
timeFrame: From enrollment until 6 months after discharge
measure: Head circumference
timeFrame: From enrollment until 6 months after discharge
measure: Mid-upper arm circumference
timeFrame: From enrollment until 6 months after discharge
measure: Length in children <2 years of age
timeFrame: From enrollment until 6 months after discharge
Secondary outcomes:
measure: Body composition
timeFrame: From enrollment until 6 months after discharge
measure: Duration and frequency of nutritional support
timeFrame: From enrollment until 6 months after discharge
measure: Dependency on nasogastric tube feeding
timeFrame: From enrollment until 6 months after discharge
measure: Nutritional requirements and intake
timeFrame: From enrollment until 6 months after discharge
measure: Nutritional requirements and intake
timeFrame: From enrollment until 6 months after discharge
measure: Nutritional requirements and intake
timeFrame: From enrollment until 6 months after discharge
measure: Nutritional requirements and intake
timeFrame: From enrollment until 6 months after discharge
measure: Feeding behaviour of the child
timeFrame: From enrollment until 6 months after discharge
measure: Feeding behaviour of the child
timeFrame: From enrollment until 6 months after discharge
measure: Parental stress
timeFrame: From enrollment until 6 months after discharge
measure: Parental stress
timeFrame: From enrollment until 6 months after discharge
measure: Quality of Life of children and parents
timeFrame: From enrollment until 6 months after discharge
measure: Cost-effectiveness of tailored nutritional care
timeFrame: From enrollment until 6 months after discharge
measure: Cost-effectiveness of tailored nutritional care
timeFrame: From enrollment until 6 months after discharge
measure: Barriers and facilitators of implementation of the multidisciplinary support team
timeFrame: From enrollment until 6 months after discharge
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: ErasmusMC
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Sascha C Verbruggen
role: PRINCIPAL_INVESTIGATOR
References: