## Protocol Section
### Identification Module
**NCT ID:** NCT06414200

**Acronym:** NutriCAD

**Brief Title:** Nutritional Care After Discharge in Children Term Born-18years Old

**Official Title:** Nutritional Care After Hospital Discharge

#### Organization Study ID Info
**ID:** NL84484.078.23
#### Organization
**Class:** OTHER
**Full Name:** Erasmus Medical Center
### Status Module
#### Completion Date
**Date:** 2027-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-12-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-02
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Erasmus Medical Center

#### Responsible Party

**Investigator Affiliation:** Erasmus Medical Center

**Investigator Full Name:** S.C.A.T Verbruggen

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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:

### Conditions Module

**Conditions:**

- Malnutrition, Child

**Keywords:**

- Nutritional care

- After discharge

- Pediatric

### Design Module

#### Design Info

**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

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 260

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Label:** Control group/usual care group

**Type:** NO_INTERVENTION

#### Arm Group 2

**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.

**Intervention Names:**

- Other: multidisciplinary structured tailored made nutritional advice

**Label:** Intervention group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention group

**Description:** 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).

**Name:** multidisciplinary structured tailored made nutritional advice

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** in kilograms and z-scores

**Measure:** Weigth

**Time Frame:** From enrollment until 6 months after discharge

**Description:** in meters and z-scores

**Measure:** Height

**Time Frame:** From enrollment until 6 months after discharge

**Description:** in centimeters and z-scores

**Measure:** Head circumference

**Time Frame:** From enrollment until 6 months after discharge

**Description:** in centimeters and z-scores

**Measure:** Mid-upper arm circumference

**Time Frame:** From enrollment until 6 months after discharge

**Description:** in centimeters and z-scores

**Measure:** Length in children <2 years of age

**Time Frame:** From enrollment until 6 months after discharge

#### Secondary Outcomes

**Description:** Fat mass, Fat free mass

**Measure:** Body composition

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Time (weeks), frequency per day

**Measure:** Duration and frequency of nutritional support

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Yes/No and intermitted or portions

**Measure:** Dependency on nasogastric tube feeding

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Energy as kcal/day and kcal/kg

**Measure:** Nutritional requirements and intake

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Protein as gram/day and gram/kg

**Measure:** Nutritional requirements and intake

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Fluids as ml/day and ml/kg

**Measure:** Nutritional requirements and intake

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Total mineral an vitamin intake percentage of ADH

**Measure:** Nutritional requirements and intake

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Questionnnaire CEBQ/BEBQ

**Measure:** Feeding behaviour of the child

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Questionnnaire MCH-FS

**Measure:** Feeding behaviour of the child

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Questionnaire LTO

**Measure:** Parental stress

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Questionnaire PROMIS

**Measure:** Parental stress

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Questionnaire CHU9D

**Measure:** Quality of Life of children and parents

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Questionnaire iMCQ

**Measure:** Cost-effectiveness of tailored nutritional care

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Questionnaire iPCQ

**Measure:** Cost-effectiveness of tailored nutritional care

**Time Frame:** From enrollment until 6 months after discharge

**Description:** Interviews with parents

**Measure:** Barriers and facilitators of implementation of the multidisciplinary support team

**Time Frame:** From enrollment until 6 months after discharge

### Eligibility Module

**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

**Maximum Age:** 18 Years

**Minimum Age:** 7 Days

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** e.vansteenbergen@erasmusmc.nl

**Name:** Esther J van Steenbergen, Msc

**Phone:** +31107030380

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rotterdam

**Contacts:**

***Contact 1:***

- **Email:** e.vansteenbergen@erasmusmc.nl

- **Name:** Esther J van Steenbergen, Msc

- **Phone:** +31611759908

- **Role:** CONTACT

***Contact 2:***

- **Name:** Sascha C Verbruggen, dr.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Netherlands

**Facility:** ErasmusMC

**State:** Zuid-Holland

**Zip:** 3015 CN

#### Overall Officials

**Official 1:**

**Affiliation:** Erasmus Medical Center

**Name:** Sascha C Verbruggen

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009748

- Term: Nutrition Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M25306

- Name: Malnutrition

- Relevance: HIGH

- As Found: Malnutrition

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M18049

- Name: Child Nutrition Disorders

- Relevance: HIGH

- As Found: Malnutrition, Child

### Condition Browse Module - Meshes

- ID: D000044342

- Term: Malnutrition

- ID: D000015362

- Term: Child Nutrition Disorders

### Misc Info Module

- Version Holder: 2024-05-31
