WP09 Outcome assessment-Neurodevelopment

Workpackage leader:

Prof. Neil Marlow, UCL

Workpackage partners:
UCC
K.U.Leuven
CUNI
CHU
UCD
CWIUH
UALBERTA

Workpackage Objectives

  • Definition of the neurodevelopmental primary and secondary long term outcomes
  • Training an assessor from each centre in the agreed assessment protocol
  • Quality assurance of the 2-year outcome evaluations

 

Workpackage Description

Very preterm children are at risk of a range of developmental problems as they grow up. We will evaluate children for signs of serious neurological problems (such as cerebral palsy, blindness or deafness), developmental progress and behaviour, in addition to evaluation of the support required to optimise development. We will do this by:

  • Face to face assessments by a paediatrician: This is done at 12 and 24 months of age corrected for preterm birth
    • Each paediatrician will be trained in the study techniques and will be accredited to ensure high quality results
    • The doctor will carry out a full examination of the nervous system and discuss each child's progress with the parents, recording this in a standard way so we can compare how children in both study groups are faring.
  • Parental diaries: parents are asked to keep a record of contacts with members of the health team (doctors, nurses, health visitors, physiotherapists, etc) in a diary, which they are given at discharge from the hospital.
  • Parents will also complete a questionnaire at 2 years to describe their child's behaviour.

All of the data is fed back to the study centre where it is placed onto databases for analysis. Parents also receive a summary of their assessments for their own records and to give to their paediatrician or family doctor if they so wish.

The work package is made up of a range of tasks or milestones:

Task 1: agree the standard tests that form the assessment.

Task 2: prepare the dummy tables with which to report outcomes up to 2 years.

Task 3: design the diary and questionnaires based on the information from Task 1.

Task 4: design the materials and training course for the paediatrician's assessment (in conjunction with WP 02).

Task 5: develop an SOP on how to record and report neurodevelopmental outcome.

Task 6: train assessors from each participating centre (in conjunction with WP 02).

Task 7: supervise and monitor outcome evaluations, coordinated locally.

Task 8: collate results of outcome assessments, data entry and checking; analysis of study outcomes with WP 12.

Task 9: develop a separate protocol for longer term evaluation of this cohort at early school age (7 years) and prepare this for submission to suitable funding agencies.

Task 10: provide recommendations for social, economic and community resources required for improving health status in children with seizures in the neonatal period.