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Follow-up at two years

Follow-up at two years

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Follow-up at two years

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  1. Follow-up at two years INIS International Neonatal Immunotherapy Study

  2. INIS: follow-up at two years Outcomes • Primary • Mortality and Major disability at 2 years corrected • Secondary : long term • Non-Major disability at 2 years • Number of hospital admissions

  3. INIS: follow-up at two years Recruitment aim: 5,000 children > 90% follow-up Followed up to two years corrected for gestational age Timetable: • 1st child 2 years corrected Dec 2003 • Recruitment continues until July 2006 • Last child follow-up in December 2008

  4. INIS: follow-up at two years Domains for assessment of disability • Developmental - Cognitive - non-verbal and verbal - Motor

  5. INIS: follow-up at two years • Special senses - vision - hearing

  6. INIS: follow-up at two years • General Health Seizures Feeding Respiratory Renal Other disability • Hospital admissions • Height and Weight

  7. INIS: follow-up at two years Neurological impairment • Cerebral palsy • Hydrocephalus • Other neuromotor Other concerns – possibly related to participation Other diagnoses

  8. INIS: follow-up at two years Tools used: Professionals Parents

  9. INIS: follow-up at two years Tools used: • Non-verbal cognition PARCA – Parent report of children’s abilities (A) • Verbal cognition Macarthur – short form – parent completed (C)

  10. INIS: follow-up at two years Non-verbal cognition and Verbal cognition • Used in TEDS (Twins early development study – Saudino and PLomin et al) • Modified and evaluated in UKOS trial (Marlow and Johnson et al) • Correlation with MDI Bailey Scales (BSID II) composite score r = 0.64 p <0.0001 • Diagnostic utility for MDI < 70 – sensitivity and specificity 81%

  11. INIS: follow-up at two years Health Status at 2 years Questionnaire (HSQ) : Disability • Developed by consensus meeting UK (NPEU and Oxford HA) – 1993 • Criteria for disability defined • Used in similar form for paediatricians in UKOS trial

  12. INIS: follow-up at two years Health Status at 2 years Questionnaire (HSQ) • Professionals and parents • Maximise response • Allow evaluation of parent report • First use by parents

  13. INIS: follow-up at two years

  14. INIS: follow-up at two years

  15. INIS: follow-up at two years

  16. INIS: follow-up at two years

  17. INIS: follow-up at two years Co-ordination of follow-up • Trial Centre sends all forms • Parents • Discussed at time of discharge / address • Birthday cards • letter sent 6 weeks before 2 years post term • Questionnaire to parents in time to be completed at two years post term

  18. INIS: follow-up at two years Co-ordination of follow-up • Paediatricians - Local co-ordinator sent form before discharge asking for contact name / address of Paediatrician who will see child at two years - 6 months before child 2 years post term contact made with named paediatrician - Questionnaire sent prior to two year assessment