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

July 10, 2026 updated by: S.C.A.T Verbruggen, Erasmus Medical Center

Nutritional Care After Hospital Discharge (NutriCAD): A Stepped Wedged Multicentre Randomized Controlled Trial in Paediatrics

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Alkmaar, Netherlands, 1815JD
        • Recruiting
        • Noordwest Ziekenhuisgroep
        • Contact:
        • Principal Investigator:
          • Eefje Winder-Bakker, Msc
      • Breda, Netherlands, 4818CK
        • Recruiting
        • Amphia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Herbert van Wering, PhD
      • Dordrecht, Netherlands, 3300AK
        • Recruiting
        • Albert Schweitzer Ziekenhuis
        • Contact:
          • Ankie Lebon, PhD
          • Phone Number: +31078 654 11 11
          • Email: a.lebon@asz.nl
        • Contact:
        • Principal Investigator:
          • Ankie Lebon, PhD
      • Ede, Netherlands, 6716RP
        • Recruiting
        • Ziekenhuis Gelderse Vallei
        • Contact:
        • Contact:
          • Esmee Kroon, Bsc
          • Phone Number: +310318 434 343
          • Email: ekroon@zgv.nl
        • Principal Investigator:
          • Renske Bottema, PhD
      • Eindhoven, Netherlands, 5623EJ
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 CN
        • Recruiting
        • ErasmusMC
        • Contact:
        • Principal Investigator:
          • Sascha C Verbruggen, dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group/usual care group
The usual care as given at that moment in that hospital. The group to compare the intervention with.
Active Comparator: 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.
Other: A structured follow-up with a tailored made nutritional plan and a parent empowerment program
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height
Time Frame: From enrollment until 6 months after discharge
in meters and z-scores
From enrollment until 6 months after discharge
Head circumference
Time Frame: From enrollment until 6 months after discharge
in centimeters and z-scores
From enrollment until 6 months after discharge
Mid-upper arm circumference
Time Frame: From enrollment until 6 months after discharge
in centimeters and z-scores
From enrollment until 6 months after discharge
Length in children <2 years of age
Time Frame: From enrollment until 6 months after discharge
in centimeters and z-scores
From enrollment until 6 months after discharge
Weight
Time Frame: From enrollment until 6 months after discharge
in kilograms, cm and z-scores
From enrollment until 6 months after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: From enrollment until 6 months after discharge
Fat mass, Fat free mass
From enrollment until 6 months after discharge
Duration and frequency of nutritional support
Time Frame: From enrollment until 6 months after discharge
Time (weeks), frequency per day
From enrollment until 6 months after discharge
Dependency on nasogastric tube feeding
Time Frame: From enrollment until 6 months after discharge
Yes/No and intermitted or portions
From enrollment until 6 months after discharge
Nutritional requirements and intake
Time Frame: From enrollment until 6 months after discharge
Energy as kcal/day and kcal/kg
From enrollment until 6 months after discharge
Nutritional requirements and intake
Time Frame: From enrollment until 6 months after discharge
Protein as gram/day and gram/kg
From enrollment until 6 months after discharge
Nutritional requirements and intake
Time Frame: From enrollment until 6 months after discharge
Fluids as ml/day and ml/kg
From enrollment until 6 months after discharge
Nutritional requirements and intake
Time Frame: From enrollment until 6 months after discharge
Total mineral an vitamin intake percentage of ADH
From enrollment until 6 months after discharge
Feeding behaviour of the child
Time Frame: From enrollment until 6 months after discharge
Questionnnaire CEBQ/BEBQ
From enrollment until 6 months after discharge
Feeding behaviour of the child
Time Frame: From enrollment until 6 months after discharge
Questionnnaire MCH-FS
From enrollment until 6 months after discharge
Parental stress
Time Frame: From enrollment until 6 months after discharge
Questionnaire LTO
From enrollment until 6 months after discharge
Parental stress
Time Frame: From enrollment until 6 months after discharge
Questionnaire PROMIS
From enrollment until 6 months after discharge
Quality of Life of children and parents
Time Frame: From enrollment until 6 months after discharge
Questionnaire CHU9D
From enrollment until 6 months after discharge
Cost-effectiveness of tailored nutritional care
Time Frame: From enrollment until 6 months after discharge
Questionnaire iMCQ
From enrollment until 6 months after discharge
Cost-effectiveness of tailored nutritional care
Time Frame: From enrollment until 6 months after discharge
Questionnaire iPCQ
From enrollment until 6 months after discharge
Barriers and facilitators of implementation of the multidisciplinary support team
Time Frame: After the intervention
Interviews with parents and health care professionals
After the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: Sascha C Verbruggen, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL84484.078.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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