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

Nutritional Care After Hospital Discharge

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: Not yet recruiting
• Conditions: Malnutrition, Child
• Intervention / Treatment: Other: multidisciplinary structured tailored made nutritional advice

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:

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esther J van Steenbergen, Msc; Phone Number: +31107030380; Email: e.vansteenbergen@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 CN
      • ErasmusMC
      • Contact: Esther J van Steenbergen, Msc; Phone Number: +31611759908; Email: e.vansteenbergen@erasmusmc.nl
      • Principal Investigator: Sascha C Verbruggen, dr.

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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: multidisciplinary structured tailored made nutritional advice; 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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Sascha C Verbruggen, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 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): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric; Nutritional care; After discharge
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Child Nutrition Disorders
• 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