Early Intervention Project: a multi-level evaluation of early (physiotherapeutical) intervention in infants at high risk for the development of cerebral palsy
| ISRCTN | ISRCTN85728836 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85728836 |
| Protocol serial number | NTR361 |
| Sponsor | University Medical Centre Groningen (UMCG) (Netherlands) |
| Funders | Johanna Children's Fund (Johanna Kinderfonds) (The Netherlands), The Foundation Fund Gavere (Stichting Fonds de Gavere) (The Netherlands) |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 17/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof M Hadders-Algra
Scientific
Scientific
University Medical Center Groningen
Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands
| m.hadders-algra@med.umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Early Intervention Project: a multi-level evaluation of early (physiotherapeutical) intervention in infants at high risk for the development of cerebral palsy |
| Study acronym | VIP |
| Study objectives | Intervention with the recently developed COPCA method improves developmental outcome at 6 and 18 months more than traditional types of early physiotherapeutical intervention. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Cerebral parese (cerebral palsy) |
| Intervention | Intervention: COPCA = COPing with and CAring for infants with neurological dysfunction. Control: traditional types of early physiotherapeutical intervention. |
| Intervention type | Other |
| Primary outcome measure(s) |
Neuromotor condition. |
| Key secondary outcome measure(s) |
1. Pediatric Evaluation of Disability Inventory (PEDI) |
| Completion date | 29/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 46 |
| Key inclusion criteria | Infants who have been referred to the Neonatal Intensive Care Unit (NICU) of the Beatrix Children's Hospital of the Unversity Medical Centre Groningen (UMCG) and who have definitely abnormal general movements at the corrected age of 3 months. |
| Key exclusion criteria | 1. Presence of severe congenital anomaly 2. Inappropriate parental understanding of the Dutch language |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 29/02/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2011 | Yes | No | |
| Results article | results | 01/04/2019 | 17/06/2019 | Yes | No |
Editorial Notes
17/06/2019: Publication reference and total final enrolment added.
