Nutritional Care After Discharge in Children Term Born-18years Old (NutriCAD)

Erasmus University

Status: Not yet enrolling

Conditions: Malnutrition, Child

Treatments: Other: multidisciplinary structured tailored made nutritional advice

Study type: Interventional

Funder types: Other

Identifiers

NCT06414200

NL84484.078.23

Details and patient eligibility

About

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

Full 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:

Enrollment: 260 estimated patients

Sex: All

Ages: 7 days to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Control group/usual care group

No Intervention group

Description:

The usual care as given at that moment in that hospital. The group to compare the intervention with.

Intervention group

Active Comparator group

Description:

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.

Treatment:

Other: multidisciplinary structured tailored made nutritional advice