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

NCT06414200 | Not Yet Recruiting

• 1 other identifier: NL84484.078.23
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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

Conditions

Malnutrition, Child

Keywords

Nutritional care; After discharge; Pediatric

Outcome Measures

Primary Outcomes (5)

• Weigth

  in kilograms and z-scores

  From enrollment until 6 months after discharge

• Height

  in meters and z-scores

  From enrollment until 6 months after discharge

• Head circumference

  in centimeters and z-scores

  From enrollment until 6 months after discharge

• Mid-upper arm circumference

  in centimeters and z-scores

  From enrollment until 6 months after discharge

• Length in children <2 years of age

  in centimeters and z-scores

  From enrollment until 6 months after discharge

Secondary Outcomes (15)

• Body composition

  From enrollment until 6 months after discharge

• Duration and frequency of nutritional support

  From enrollment until 6 months after discharge

• Dependency on nasogastric tube feeding

  From enrollment until 6 months after discharge

• Nutritional requirements and intake

  From enrollment until 6 months after discharge

• Nutritional requirements and intake

  From enrollment until 6 months after discharge

Study Arms (2)

Control group/usual care group

NO INTERVENTION

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

Intervention group

ACTIVE COMPARATOR

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.

Other: multidisciplinary structured tailored made nutritional advice

Interventions

multidisciplinary structured tailored made nutritional advice OTHER

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).

Intervention group

Eligibility Criteria

• Age: 7 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

ErasmusMC

Rotterdam, South Holland, 3015 CN, Netherlands

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Sascha C Verbruggen

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther J van Steenbergen, Msc

CONTACT

+31107030380; e.vansteenbergen@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 16, 2024
• Study Start: December 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)