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: 1 st 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 ParentPaediatrician Cognition Non-verbal PARCA A. Clinical opinion Q. 31 Verbal Speech and language Macarthur (short) B HSQ MotorHSQ

14. INIS: follow-up at two years ParentPaediatrician VisionHSQHSQ + aetiology squint HearingHSQHSQ + aetiology SeizuresHSQ FeedingHSQ

15. INIS: follow-up at two years ParentPaediatrician RespiratoryHSQ + RenalHSQ OtherHSQ Hospital admissions More detail on reasons

16. INIS: follow-up at two years ParentPaediatrician Cerebral palsy Number limbs involved Neurological exam Height and weight Measurements

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