|- candidate number||1571|
|- NTR Number||NTR361|
|- Date ISRCTN created||19-dec-2005|
|- date ISRCTN requested||28-okt-2005|
|- Date Registered NTR||12-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Early Intervention Project.|
|- Scientific Title||A multi-level evaluation of early (physiotherapeutical) intervention in infants at high risk for the development of cerebral palsy.|
|- hypothesis||Intervention with the recently developed COPCA method improves developmental outocme at 6 and 18 months more than traditional types of early physiotherapeutical intervention.|
|- Healt Condition(s) or Problem(s) studied||Cerebral palsy|
|- Inclusion criteria||Infants who have been referred to the NICU of the Beatric Children's Hosptial of the UMCG and who have definitely abnormal general movements at the corrected age of 3 months.|
|- Exclusion criteria||1. Presence of severe congenital anomaly;|
2.Inappropriate parental understanding of the Dutch language.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-mrt-2003|
|- planned closingdate||29-feb-2008|
|- Target number of participants||40|
|- Interventions||COPCA = COPing with and CAring for infants with neurological dysfunction.|
|- Primary outcome||Neuromotor condition.|
|- Secondary outcome||1. PEDI;
2. KID-N and Bayley MDI;
3. Parameters of postural control;
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. M. Hadders-Algra|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. M. Hadders-Algra|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Beatrix Children's Hospital|
(Source(s) of Monetary or Material Support)
|Johanna Kinderfonds, Stichting Fonds de Gavere|
|- Publications||Hospers CH, Van der Graaf-Peters VB, Hadders-Algra M. Het vroegtijdige interventie project in Groningen. Ned Tijdschr Kinderfysiother, 2004; 16, nr 40: 14-16.|
Hadders-Algra M, Dirks T, Blauw-Hospers C, De Graaf-Peters V. The Kozijavkin method: giving parents false hope? Lancet 2005; 365:842.
Blauw-Hospers CH, Hadders-Algra M. A systematic review on the effects of early intervention on motor development. Dev Med Child Neurol 2005; 47: 421-32.
|- Brief summary||The VIP project is designed for children with a high risk of the development of developmental disabilities. |
Recently, it has been demonstrated that the quality of general movements (GM), i.e. complex movements which involve head, trunk and legs, at the age of 2 to 4 months corrected age has a predictive value for further developmental outcome.
Definitely abnormal GM’s at this age are associated with a high risk for the development of cerebral palsy. The early detection of infants at high risk offers the opportunity for intervention at young age during a phase in which the central nervous system is characterized by high plasticity.
A new type of intervention named COPCA, Coping with and Caring for infants with neurological dysfunction, is evaluated in this project.
The goals of the project are to evaluate the COPCA intervention on motor and psychosocial functioning of the child and autonomy of the child and its parents and to evaluate the application of COPCA in daily practice. To this end, 40 infants with definitely abnormal General Movements in the tenth week corrected age will be selected.
The children will be recruited from the children born in the UMC Groningen. After randomization these children will be allocated into two groups of 20 children, COPCA or control.
The effects of the COPCA intervention are determined at both short (during and immediately after intervention) and long term (1 year after the end of the intervention).
The evaluation focuses on 3 functional levels:
a) neuromotor functioning,
b) psychosocial functioning, including parent-infant interaction,
c) neurophysiological parameters of postural control.
|- Main changes (audit trail)|
|- RECORD||12-sep-2005 - 6-mrt-2006|