The PEPI ARC study: Feasibility study for early detection of cerebral palsy in pre term infants

Not Applicable

Recruiting

• Conditions: cerebral palsy; Neurological - Other neurological disorders

• Registration Number: ACTRN12623000600640
• Lead Sponsor: Te Whatu Ora - Capital Coast District Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-01
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All infants admitted to Wellington NICU who meet the inclusion criteria and their parent/caregivers will be invited to participate in PEPI ARC. There are no limits placed on sample size and a formal sample size calculation is not required. The alternative option is to continue with standard care.

Eligibility
i.Admitted to the NICU at Wellington Regional Hospital.
ii.Survived until discharge from NICU.
iii.Discharge address located within the Wellington region or within one of Wellington NICU’s referral regions.
iv.Meet the Best Practice Recommendations criteria for risk of CP.

Inclusion criteria
1.Any Infant born less than 28+0 weeks gestation
Or
2. Infant born at or after 28+0 weeks’ gestation with one or more detectable risk factors for CP:

i.Weight less than 1000 g.
ii.Intrauterine growth restriction.
Birth weight less than 3rd percentile on population-based or customized growth charts or at clinician’s discretion based on concern about pathological growth restriction.
iii.Abnormal findings on neuroimaging associated with CP.
(e.g., grade 3 and 4 intraventricular haemorrhage, post haemorrhagic ventricular dilatation, hydrocephalus, periventricular leukomalacia (PVL), stroke, brain maldevelopment).
iv.Grade 2 or 3 hypoxic ischaemic encephalopathy (HIE).
v.Neonatal encephalopathy of other aetiology.
vi.Neonatal meningitis/ encephalitis - bacterial or viral.
vii.Cardiac surgery.
viii.Clinical or parental concerns or other significant risk factor – clinician discretion

Surveys will be distributed to health professionals involved in the above infants care or seek information through contacting the Hub. Health professionals are not study participants.

Exclusion Criteria

Exclusion Criteria
i.Infant born with a life limiting condition and not expected to survive past the first year of life.
ii.Whanau chose standard care.
iii.Infant and whanau discharge address is outside Wellington NICU’s catchment area or they are expected to move out of the catchment area before 3 months corrected gestational age.

Study & Design

• Study Type: Interventional
• Study Design: Not specified