Nutritional Care After Discharge in Children Term Born-18years Old
ConditionMalnutrition, Child
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-18
SponsorErasmus Medical Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
A structured follow-up with a tailored made nutritional plan and a parent empowerment program
Other interventionThe 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).
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: Control group/usual care groupNo intervention 0 interventions
Group B: Intervention groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Weight
in kilograms, cm and z-scores
Time frame
From enrollment until 6 months after discharge2
Height
in meters and z-scores
Time frame
From enrollment until 6 months after discharge3
Head circumference
in centimeters and z-scores
Time frame
From enrollment until 6 months after discharge4
Mid-upper arm circumference
in centimeters and z-scores
Time frame
From enrollment until 6 months after dischargeSecondary outcomes
1
Body composition
Fat mass, Fat free mass
Time frame
From enrollment until 6 months after discharge2
Duration and frequency of nutritional support
Time (weeks), frequency per day
Time frame
From enrollment until 6 months after discharge3
Dependency on nasogastric tube feeding
Yes/No and intermitted or portions
Time frame
From enrollment until 6 months after discharge4
Nutritional requirements and intake
Energy as kcal/day and kcal/kg
Time frame
From enrollment until 6 months after dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov