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
Secondary identifying numbers	NTR361

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Prof M Hadders-Algra
Scientific

University Medical Center Groningen
Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands

Email	m.hadders-algra@med.umcg.nl

Study design	Randomised active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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 hypothesis	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
Condition	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	Neuromotor condition.
Secondary outcome measures	1. Pediatric Evaluation of Disability Inventory (PEDI) 2. KID-N and Bayley MDI 3. Parameters of postural control 4. NVOS 5. MPOC
Overall study start date	01/03/2003
Overall study end date	29/02/2008

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	40
Total final enrolment	46
Participant 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.
Participant exclusion criteria	1. Presence of severe congenital anomaly 2. Inappropriate parental understanding of the Dutch language
Recruitment start date	01/03/2003
Recruitment end date	29/02/2008

University Medical Center Groningen

Groningen
9700 RB
Netherlands

University Medical Centre Groningen (UMCG) (Netherlands)
Hospital/treatment centre

Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands

Website	http://www.umcg.nl/azg/nl/english/azg/
"ROR"	https://ror.org/03cv38k47

Charity

Johanna Children's Fund (Johanna Kinderfonds) (The Netherlands)

No information available

The Foundation Fund Gavere (Stichting Fonds de Gavere) (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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

17/06/2019: Publication reference and total final enrolment added.