|- candidate number||17594|
|- NTR Number||NTR4542|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-apr-2014|
|- Secondary IDs||14-N-13 |
|- Public Title||Factors associated with an underlying somatic cause in children with developmental and/or behavioral disability|
|- Scientific Title||Retrospective cohort study to identify red flags pointing towards an underlying somatic cause of developmental and/or behavioral disability in children|
|- hypothesis||We expect that when the developed checklist will be used in de diagnostic proces of children with developmental and/or behavioral disability, the use of pediatric care will be more efficiently used. Over and underdiagnoses of a causal somatic disease will be prevented.
|- Healt Condition(s) or Problem(s) studied||Developmental disorder, Behavioural disorders, Mental disorders, Children|
|- Inclusion criteria||0-7 years, applied to Integrative preschool team Zuid-Limburg between 1st of January and the 31st of December 2012 |
|- Exclusion criteria||Children that had been examined before in the same team setting|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||5-mei-2014|
|- planned closingdate||18-jul-2014|
|- Target number of participants||200|
|- Interventions||Check database for:|
* Information about pregnancy and delivery, medical history, household composition etc
* Outcome psychological tests: IQ test by SON, BSID or WPPSI
* Outcome examination by a pediatrician: - - physical examination
- genetic investigations
- Metabolic investigations
|- Primary outcome||Identify red flags that point in the direction of an underlying somatic cause that explains the developmental and/or behavioral disability in children|
|- Secondary outcome||Yield of metabolic and genetic investigation children with mental retardation.|
|- Timepoints||Retrospective cohort study: 4 months before analysis will be done|
|- Trial web site|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| T. Severijns|
|- CONTACT for SCIENTIFIC QUERIES|| T. Severijns|
|- Sponsor/Initiator ||Atrium Medical Center, Heerlen|
(Source(s) of Monetary or Material Support)
|Atrium Medical Center, Heerlen|
|- Brief summary||INTRODUCTION Health in childhood can be improved by early detection and treatment of developmental disabilities to prevent further harm. In the Netherlands, early detection is achieved by use of the Van Wiechen surveillance measure in Primary-Health-Care. Besides, parents may apply to the Integrative preschool team (Integrale Vroeghulp)’, a Dutch initiative to diagnose developmental and behavioral disability in a multidisciplinary team of psychologists, behavioral therapists and social workers. To prevent a delay in referral for pediatric diagnosis, there is need for an instrument to decide whether further investigation is indicated. |
The aim of this study was to develop an instrument to identify those children that should undergo pediatric examination in order to prove or exclude a medical underlying disease.
METHODS We included around 200 individuals, aged 0-7 years. All were seen by the team and a pediatrician, who decided upon genetic, metabolic and neurological investigations.
Statistics Logistic regression was used to identify risk factors associated with an underlying somatic cause of developmental and/or behavioral problems. The ROC curve and its AUC were used to identify the optimum cut off point of continuous variables.
RESULTS Odds Ratio’s and its significance will be shown for each potential risk factor.
CONCLUSION We will discuss which (combination of) risk factors in young children with developmental and/or behavioral problems are significant in order to predict a pediatric underlying cause. Furthermore, we will show the regression coefficient for each significant risk factor and the optimum cut off value for the continuous variables.
|- Main changes (audit trail)|
|- RECORD||29-apr-2014 - 21-mei-2014|