The aim of our study 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 behaviour and…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in growth parameters weight, length and head circumference at 6
months after discharge.
Secondary outcome
The change in: 1) Body composition (fat mass, fat free mass), 2) Duration and
frequentie of nutritional support and/or dependency on nasogastric tube
feeding, 3) Nutritional requirements and intake, 4) Feeding behaviour of the
child, 5) Parental stress, 6) Quality of Life of children and parents, 7)
Cost-effectiveness of tailored nutritional care, and 8) Barriers and
Facilitators of Implementation of the multidisciplinary support team 6 months
after discharge
Background summary
In the Netherlands after hospitalization 9% of children are malnourished or at
(high) risk of becoming malnourished. Impaired nutritional status influences
time to recovery and has a negative effect on physical, emotional, social and
cognitive functioning of children, and even on the Quality of Life and stress
of caregivers. After discharge from hospital the exact time span in which the
nutritional status is normalized is unclear. Currently children and parents are
not followed-up by a nutritional support team while care is often left to a
*multitude of healthcare professionals in various care settings*.
Study objective
The aim of our study 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
behaviour and quality of life (QoL) in children and their parents. Furthermore,
the effect on parental stress, anxiety, depression, and posttraumatic stress
(PTSD) as well as QoL will be assessed with and without a tailored nutritional
care follow-up program.
Study design
A randomized stepped wedged study to compare usual care with nutritional home
support.
Intervention
A tailor-made nutritional plan at discharge and adjustments after follow-up
encounters at 6-12 and 18 weeks after discharge. The following aspects will be
evaluated: feeding difficulties and behaviors, plus the stress of the parents.
The answers of the questionnaires will be displayed in a digital dashboard.
Study burden and risks
For the children enrolled in the study there might be benefits in the
intervention group. No harm is expected in the usual care or intervention
group. It will be made clear during the informed consent process that
participation in this study might have benefit in the intervention group and no
direct benefit in the usual care group and that a refusal will not have impact
on their care received by the medical staff.
As well as the time investment in filling out the questionnaires. It should be
clear for the participant before starting with this study how much time the
study procedures cost. So, participants can make a decision based on realistic
information. The project will meet an important clinical, societal, and
scientific need and will ultimately lead to an improvement in the care for sick
and malnourished children who are receiving nutritional support at home.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
Children (Term born neonates - 18 years) admitted with newly initiated
nutritional support (oral and/or enteral nutritional support) during
hospitalization which is recommended to continue 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | Is in aanvraag |
CCMO | NL84484.078.23 |