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SHINYA HIRANO, M.D. 1 ） MASANORI FUJIMURA, M.D. 1 ） Neonatal Research Network Japan 1 ） Department of Neonatal Medici

Better Developmental function at 3 years for infants born at 22-23wks who participated in the Randomized Controlled Trial for the Prevention of Intraventricular Hemorrhage by Indomethacin in Japanese Extremely Low Birthweight Infants. SHINYA HIRANO, M.D. 1 ） MASANORI FUJIMURA, M.D. 1 ）

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SHINYA HIRANO, M.D. 1 ） MASANORI FUJIMURA, M.D. 1 ） Neonatal Research Network Japan 1 ） Department of Neonatal Medici

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  1. Better Developmental function at 3 years for infants born at 22-23wks who participated in the Randomized Controlled Trial for the Prevention of Intraventricular Hemorrhage by Indomethacin in Japanese Extremely Low Birthweight Infants SHINYA HIRANO, M.D.1）MASANORI FUJIMURA, M.D.1） Neonatal Research Network Japan 1） Department of Neonatal Medicine, Osaka Medical Center for Maternal and Child Health, Izumi, Osaka, Japan.

  2. Has documented that he/she has no financial relationships to disclose or Conflicts of Interest (COIs) to resolve. SHINYA HIRANO

  3. Indomethacin Trial • 【Subjects】 • To fulfill all of the following; • Birth weight: 400g-999g • Gestation: 22 weeks 0 day ≤ • 24 weeks ≤ & birth weight standard deviation -2.0< • 【Method】 • • Starting within 6 hours of birth 3 doses of IND or placebo were given with 6 hours continuous i.v. infusion every 24 hours. • • IND was given at the dose of 0.1 mg/kg-wt/dose. • 【Outcomes】 • Primary : IVH Grade III or IV within 7days • Secondary : Cerebral palsy, DQ at 3 year of age

  4. 718 infants assessed for eligibility 50 : Excluded 67 : Not approached Stratified factors Institution G.W Sex In- / Out-born Apgar at 1min 601 infants eligible 132 : No consent 469 infants 235 IND 234placebo Death : 29 Drop out, No data : 18 Death : 22 Drop out, No data : 22 191 187 378 / 418 (90.4%)

  5. IVH Grade III or IV within 7days odds ratio (95% CI) 0.37 (0.18-0.77) effective to prevent severe Intraventricular hemorrhage (IVH) (2005 SPR)

  6. Cerebral palsy and/or Death around 3 years did not reduce the incidence of CP and/or Death (2008 SPR/ASPR)

  7. Incidence of IVH Grede III or IV and “CP or Death “ stratified by Birth weight group the incidence of “severe IVH” and “CP or death” significantly reduced in 400-599g (2008 SPR/ASPR)

  8. Stratified by gestational weeks Seem to be effective to reduce “severe IVH” and “CP or death” in 22-23wks (2008 SPR/ASPR)

  9. 【 Objective 】 To compare the developmental quotient (DQ) using the Kyoto Scale of Psychological Development (KSPD) at 3 years between the two groups (IND or placebo) in follow-up study.

  10. The KSPD (the kyoto scale of psychological development) : • • a standardized developmental function assessment tool for Japanese infants • • widely used at child counseling centers and at public health centers • • expressed as the developmental age (DA) for three areas • Cognitive-Adaptive (C-A) • Language-Social (L-S) • Postural-Motor (P-M) • Total score ; adding up for the three areas • • DQ: calculated dividing the DA by chronological age, • then multiplied by 100

  11. ( ) 469 IND 235 Placebo 234 Death : 22 Drop out or no data: 22 Death : 29 Drop out or no data: 18 191 187 Kyoto Scale of Psychological Development (KSPD) at 3 years 171 160

  12. Baseline Characteristics 1 Mean±1SD

  13. Baseline Characteristics 2

  14. Comparison of KSPD -DQ P=0.09 P=0.16 P=0.10 P=0.38 171 160 161 157 168 161 168 161 Postural-Motor Total Score Language-Social Cognitive-Adaptive

  15. Comparison of Total Score DQ - by Birthweight group p=0.92 p=0.26 p=0.16 14 10 115 107 42 43 400-599g 600-899g 900-999g

  16. Comparison of Total Score DQ -categorized by G.W. p=0.042 p=0.06 p=0.06 12 9 101 88 67 72 22-23W 24-26W 27W-

  17. 22－23wBaseline Characteristics Mean±SD

  18. Conclusions: • There was no significant difference of DQ for all areas at 3 years evaluated by KSPD between IND and Placebo group in a large RCT in Japan. • 2. In secondly analysis using the category of GW and Birthweight, DQ of IND group was significantly higher than that of Placebo group in 22-23GW group. • 3. We have shown that Prophylactic use of indomethacin for prevention of IVH is effective in reducing CP and improving DQ for 22-23GW Japanese infants.

  19. DISCLOSURE STATEMENT Speaker: SHINYA HIRANO Dr. NAME has disclosed the following financial relationships. Any real or apparent conflicts of interest related to the content of this presentation have been resolved.

  20. Unapproved or Off Label Disclosures for INSERT NAME Presenter:NAME has documented that his/her presentation will not involve discussion of unapproved or off-label, experimental or investigational use. or-- Presenter:NAME has documented that his/her presentation involves comments or discussion of unapproved or off-label, experimental or investigational use of <<identify products, drugs or devices>>.

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