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Pediatric Academic Societies and Asian Society for Pediatric Research 2008 Joint Meeting

Pediatric Academic Societies and Asian Society for Pediatric Research 2008 Joint Meeting Platform Session Neonatal Medicine: Clinical Trials I Sunday, May 4 7:00am-9:00am Hawaii Convention Center, Ballroom B. Prevalence of cerebral palsy at 3-5 years of age

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Pediatric Academic Societies and Asian Society for Pediatric Research 2008 Joint Meeting

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  1. Pediatric Academic Societies and Asian Society for Pediatric Research 2008 Joint Meeting Platform Session Neonatal Medicine: Clinical Trials I Sunday, May 4 7:00am-9:00am Hawaii Convention Center, Ballroom B

  2. Prevalence of cerebral palsy at 3-5 years of age • who participated in an RCT for the prevention of intraventricular hemorrhage by indomethacin in Japanese extremely low birthweight infants • Shinya Hirano, Masanori Fujimura, Satoshi Kusuda, • Hirofumi Aotani. • On behalf of the Neonatal Research Network Japan • Disclosure: The trial vials (indomethacin and placebo) were manufactured by Banyu, a subsidiary of Merck & Co. Inc., NJ, USA. • The research grant from Dept. of Maternal and Child Health, Ministry of Health and Welfare, Japan. • Any real or apparent conflict of interest related to the content of the presentation has been resolved.

  3. BACKGROUND: We reported in 2005 that the prophylactic indomethacin (IND) was effective to reduce the incidence of severe IVH in Japanese ELBW infants in a large RCT (n=419) Adjusted odds ratio (95% CI) 0.37 (0.18-0.77) p =0.007 Adjusted for institution, gestational age, sex, in/out-born, Apgar score at 1 min HYPOSESIS: The reduced incidence of severe IVH by prophylactic IND in neonatal period may result in the reduction of cerebral palsy (CP) at 3-5 years of age

  4. INDOMETHACIN TRIAL • SUBJECTS:Infants withbirthweight 400-1000 g • INTERVENTION : • Starting within 6 hours of birth 3 doses of IND or placebo were given with 6 hours continuous intravenousinfusion every 24 hours • IND was given at the dose of 0.1 mg/kg-wt/dose • OUTCOMES : • Grade 3 and 4 IVH within 7 days assessed by US. • CP at 3-5 years of age

  5. OBJECTIVE: To compare the prevalence of CP at 3-5 years between the IND and placebo groups in a follow-up study of a large RCT in Japan

  6. 718 infants assessed for eligibility 50 : Excluded 67 : Not approached 601 infants eligible Stratified factors Institution Gestational Age Sex In-born / Out-born Apgar at 1min 132 : No consent 469 infants were assigned randomly 235 IND group 234placebo group Death : 22 Drop out, No data : 22 Death : 29 Drop out, No data : 18 378 / 418 (90.4%) 191 187

  7. RESULTS : Baseline Characteristics Mean±1SD NS: not significant

  8. RESULTS: Outcomes

  9. CP Without CP Severity of IVH and Prevalence of CP IND Placebo

  10. CP Without CP Severity of IVH , PVL, and Prevalence of CP IND Placebo with PVL

  11. Subgroup Analysis as for “CP or Death”

  12. Incidence of IVH 3, 4 and “CP or Death “ Stratified by Birth weight

  13. Incidence of IVH 3, 4 and “CP or Death “ Stratified by Gestational Weeks

  14. IVH 3, 4 and Gestational Age Groups N= 5 40 70 86 116 152 P=0.0034

  15. Cerebral Palsy and Birthweight Groups N= 49 314 106 odds ratio=0.23 (0.05-0.89)

  16. CONCLUSIONS: • For the whole study subjects, there was no evidence of difference in the number of infants with “CP or death” by the prophylactic use of IND compared with placebo • The prevalence of CP in each grade of IVH showed no evidence of difference between IND and placebo groups • The prevalence of PVL showed no evidence of difference in IND and placebo groups • In a subgroup analysis, the prevalence of “CP or death” was significantly lower in infants with birthweight 400-599g in IND group than placebo group • Application of prophylactic IND to the smallest group of ELBW 400-599g is shown as effective in preventing the development of CP at 3-5 years • We thank Naohiro Yonemoto and Rintaro Morifor kind advice for statistical analysis.

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