To investigate the short-term and long-term effects of burn injuries on growth and development of paediatric patients of all ages relative to the size and degree of the burn injury.
ID
Source
Brief title
Condition
- Other condition
- Skin and subcutaneous tissue disorders NEC
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Health condition
Brandwonden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the deviation from the predicted weight curve at
twelve months post-burn (Z-scores).
Secondary outcome
Secondary endpoints include other post-burn growth and development outcomes
compared to both predicted and Dutch reference values.
Background summary
Over the past few decades, a paradigm shift has occurred in burn care towards
improving survivorship which entails identifying and treating the physical and
psychological impact of burns. Improving quality of life means striving for
scar free healing, but also includes helping patients to achieve their maximal
(pre-burn) health status. Young children and adolescents are a large subgroup
(40%) of the entire burn patient population. Paediatric patients are a
particularly vulnerable group for whom the burden of post-injury morbidity may
be experienced during the remainder of their lifetime. The nature and severity
of the body*s hypermetabolic response to burns may plausibly give rise to
developmental, growth and scar growth problems in these young patients.
Knowledge on these topics is incomplete and only pertained to a rare subgroup
of patients with extensive burns (>40% of the total body surface area).
Study objective
To investigate the short-term and long-term effects of burn injuries on growth
and development of paediatric patients of all ages relative to the size and
degree of the burn injury.
Study design
Multi-centre prospective cohort study.
Study burden and risks
Having been discharged from the hospital, the patient is still in need of
follow-up care. To limit the burden on the patient and to prevent repeated
measurement of common data, data collection and follow-up visits for the study
will take place simultaneously with the regular follow-up visits, which take
place in the outpatient clinic, at one week and three, six, twelve, and
twenty-four months post discharge. During each visit, a selection of the
following measurements will be completed (see: 2. STUDY DESIGN, page 12):
length, weight, waist circumference, handgrip strength, scar surface area, and
scar quality. Preceding the visit, the patient*s parents or legal
representatives are asked to fill in three brief questionnaires in an e-health
platform designed for regular follow-up care. The extra time needed for the
study measurements is limited to 15-20 minutes per visit. Also, the
measurements are neither hazardous nor invasive, making the burden and risk
associated with study participation negligible.
Vondellaan 13
Beverwijk 1942LE
NL
Vondellaan 13
Beverwijk 1942LE
NL
Listed location countries
Age
Inclusion criteria
1) The patient is <18 years old, at the time of the burn injury.
2) The patient has a burn injury that requires surgical treatment or admission
of 24 hours or more, at one of the three Dutch burn centres (Rode Kruis
Ziekenhuis, Maasstad Ziekenhuis, Martini Ziekenhuis).
Exclusion criteria
1) Patients with electrical burns will be excluded, as the nature and
physiology of electrical burns differs from other burn injuries.
2) Patients, parents, and caretakers with insufficient Dutch language skills,
or otherwise incapable of providing informed consent.
Design
Recruitment
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 |
|---|---|
| CCMO | NL73435.029.20 |
| Other | OND1368144 |