Malnutrition, ChildNutriCADNCT06414200
Nutritional Care After Discharge in Children Term Born-18years Old
A study testing A structured follow-up with a tailored made nutritional plan and a parent empowerment program in people with Malnutrition, Child, run by Erasmus Medical Center at 6 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 days to 18 years
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- A structured follow-up with a tailored made nutritional plan and a parent empowerment program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 6 sitesNetherlands
- Study dates
- 23 Apr 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar, 1815JD
Eefje WInder-Bakker, Msc, +31072 548 4444, e.winder-bakker@nwz.nl
Eefje Winder-Bakker, Msc
- Recruiting
Amphia
Breda, 4818CK
Herbert van Wering, PhD, +31076595 5000, hvanwering@amphia.nl
Sandra van Gils, Bsc, +31076595 5000, svangils2@amphia.nl
- Recruiting
Albert Schweitzer ziekenhuis
Dordrecht, 3300AK
Ankie Lebon, PhD, +31078 654 11 11, a.lebon@asz.nl
Merel Visser, Bsc, +31078 654 11 11, m.e.l.visser@asz.nl
- Recruiting
Ziekenhuis Gelderse Vallei
Ede, 6716RP
Renske Bottema, PhD, +310318 434 343, BottemaR@zgv.nl
Esmee Kroon, Bsc, +310318 434 343, ekroon@zgv.nl
- Recruiting
Catharina ziekenhuis
Eindhoven, 5623EJ
Janneke Stapelbroek, PhD, +31040 239 9111, janneke.stapelbroek@catharinaziekenhuis.nl
Evi van den Berg, +31040 239 9111, evi.vd.berg@catharinaziekenhuis.nl
- Recruiting
ErasmusMC
Rotterdam, South Holland, 3015 CN
Esther J van Steenbergen, Msc, +31611759908, e.vansteenbergen@erasmusmc.nl
Sascha C Verbruggen, dr.
About this study
Official title: 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
Read the 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.
- Conditions
- Malnutrition, Child
- Being tested
- A structured follow-up with a tailored made nutritional plan and a parent empowerment program
- Keywords
- Nutritional care, After discharge, Pediatric
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A structured follow-up with a tailored made nutritional plan and a parent empowerment programOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: A structured follow-up with a tailored made nutritional plan and a parent empowerment program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
in kilograms, cm and z-scores
Measured: From enrollment until 6 months after discharge
Height
in meters and z-scores
Measured: From enrollment until 6 months after discharge
Head circumference
in centimeters and z-scores
Measured: From enrollment until 6 months after discharge
Mid-upper arm circumference
in centimeters and z-scores
Measured: From enrollment until 6 months after discharge
Length in children <2 years of age
in centimeters and z-scores
Measured: From enrollment until 6 months after discharge
Secondary outcomes (15)
Body composition
Fat mass, Fat free mass
Measured: From enrollment until 6 months after discharge
Duration and frequency of nutritional support
Time (weeks), frequency per day
Measured: From enrollment until 6 months after discharge
Dependency on nasogastric tube feeding
Yes/No and intermitted or portions
Measured: From enrollment until 6 months after discharge
Nutritional requirements and intake
Energy as kcal/day and kcal/kg
Measured: From enrollment until 6 months after discharge
Nutritional requirements and intake
Protein as gram/day and gram/kg
Measured: From enrollment until 6 months after discharge
Nutritional requirements and intake
Fluids as ml/day and ml/kg
Measured: From enrollment until 6 months after discharge
Nutritional requirements and intake
Total mineral an vitamin intake percentage of ADH
Measured: From enrollment until 6 months after discharge
Feeding behaviour of the child
Questionnnaire CEBQ/BEBQ
Measured: From enrollment until 6 months after discharge
Feeding behaviour of the child
Questionnnaire MCH-FS
Measured: From enrollment until 6 months after discharge
Parental stress
Questionnaire LTO
Measured: From enrollment until 6 months after discharge
Parental stress
Questionnaire PROMIS
Measured: From enrollment until 6 months after discharge
Quality of Life of children and parents
Questionnaire CHU9D
Measured: From enrollment until 6 months after discharge
Cost-effectiveness of tailored nutritional care
Questionnaire iMCQ
Measured: From enrollment until 6 months after discharge
Cost-effectiveness of tailored nutritional care
Questionnaire iPCQ
Measured: From enrollment until 6 months after discharge
Barriers and facilitators of implementation of the multidisciplinary support team
Interviews with parents and health care professionals
Measured: After the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start23 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S.C.A.T Verbruggen, Erasmus Medical Center
- Investigators
- Sascha C Verbruggen, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414200
- Sponsor's protocol ID
- NL84484.078.23
- Acronym
- NutriCAD
- Status last verified
- Sep 2026
- First submitted
- 2 May 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data may be made available for legitimate scientific purposes upon reasonable request, subject to review by the NutriCAD steering group, a data sharing agreement, institutional approval, and applicable privacy regulations
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Care After Hospital Discharge (NutriCAD): A Stepped Wedged Multicentre Randomized Controlled Trial in Paediatrics
- ClinicalTrials.gov ID
- NCT06414200
- Acronym / sponsor ID
- NutriCAD / NL84484.078.23
- Conditions
- Malnutrition, Child
- Keywords
- Nutritional care, After discharge, Pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: A structured follow-up with a tailored made nutritional plan and a parent empowerment programThe 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. |
Who may qualify
- Ages
- 7 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A structured follow-up with a tailored made nutritional plan and a parent empowerment programThe 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). | Other | Intervention group |
Primary outcome
Weight
Time frame: From enrollment until 6 months after discharge
in kilograms, cm and z-scores
Height
Time frame: From enrollment until 6 months after discharge
in meters and z-scores
Head circumference
Time frame: From enrollment until 6 months after discharge
in centimeters and z-scores
Mid-upper arm circumference
Time frame: From enrollment until 6 months after discharge
in centimeters and z-scores
Length in children <2 years of age
Time frame: From enrollment until 6 months after discharge
in centimeters and z-scores
15 secondary outcomes
Body composition
Time frame: From enrollment until 6 months after discharge
Duration and frequency of nutritional support
Time frame: From enrollment until 6 months after discharge
Dependency on nasogastric tube feeding
Time frame: From enrollment until 6 months after discharge
Nutritional requirements and intake
Time frame: From enrollment until 6 months after discharge
Nutritional requirements and intake
Time frame: From enrollment until 6 months after discharge
Nutritional requirements and intake
Time frame: From enrollment until 6 months after discharge
Nutritional requirements and intake
Time frame: From enrollment until 6 months after discharge
Feeding behaviour of the child
Time frame: From enrollment until 6 months after discharge
Feeding behaviour of the child
Time frame: From enrollment until 6 months after discharge
Parental stress
Time frame: From enrollment until 6 months after discharge
Parental stress
Time frame: From enrollment until 6 months after discharge
Quality of Life of children and parents
Time frame: From enrollment until 6 months after discharge
Cost-effectiveness of tailored nutritional care
Time frame: From enrollment until 6 months after discharge
Cost-effectiveness of tailored nutritional care
Time frame: From enrollment until 6 months after discharge
Barriers and facilitators of implementation of the multidisciplinary support team
Time frame: After the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified participant data may be made available for legitimate scientific purposes upon reasonable request, subject to review by the NutriCAD steering group, a data sharing agreement, institutional approval, and applicable privacy regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sascha C Verbruggen principal investigator
Erasmus Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A structured follow-up with a tailored made nutritional plan and a parent empowerment program in people with Malnutrition, Child, run by Erasmus Medical Center at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esther J van Steenbergen, Msc (+31107030380, e.vansteenbergen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: From enrollment until 6 months after discharge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.