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SHINYA HIRANO, M.D. 1 ) MASANORI FUJIMURA, M.D. 1 ) Neonatal Research Network Japan 1 ) Department of Neonatal Medicine, - PowerPoint PPT Presentation


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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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Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

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.


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria
Has documented that he/she has no financial relationships to disclose or Conflicts of Interest (COIs) to resolve.

SHINYA HIRANO


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

Indomethacin Trial disclose or Conflicts of Interest (COIs) to resolve.

  • 【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


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

718 disclose or Conflicts of Interest (COIs) to resolve.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%)


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

IVH Grade III or IV within 7days disclose or Conflicts of Interest (COIs) to resolve.

odds ratio (95% CI) 0.37 (0.18-0.77)

effective to prevent severe Intraventricular hemorrhage (IVH)

(2005 SPR)


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

Cerebral palsy and/or Death around 3 years disclose or Conflicts of Interest (COIs) to resolve.

did not reduce the incidence of CP and/or Death

(2008 SPR/ASPR)


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

Incidence of IVH Grede III or IV and “CP or Death “ disclose or Conflicts of Interest (COIs) to resolve.

stratified by Birth weight group

the incidence of “severe IVH” and “CP or death” significantly reduced in 400-599g

(2008 SPR/ASPR)


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

Stratified by gestational weeks disclose or Conflicts of Interest (COIs) to resolve.

Seem to be effective to reduce “severe IVH” and “CP or death” in 22-23wks

(2008 SPR/ASPR)


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

【 Objective 】 disclose or Conflicts of Interest (COIs) to resolve.

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.


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

  • The KSPD (the kyoto scale of psychological development) : disclose or Conflicts of Interest (COIs) to resolve.

    • • 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


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

( disclose or Conflicts of Interest (COIs) to resolve.

)

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


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

Baseline Characteristics 1 disclose or Conflicts of Interest (COIs) to resolve.

Mean±1SD


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

Baseline Characteristics 2 disclose or Conflicts of Interest (COIs) to resolve.


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

Comparison of KSPD -DQ disclose or Conflicts of Interest (COIs) to resolve.

P=0.09

P=0.16

P=0.10

P=0.38

171 160 161157168 161 168 161

Postural-Motor

Total Score

Language-Social

Cognitive-Adaptive


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

Comparison of Total Score DQ - disclose or Conflicts of Interest (COIs) to resolve. by Birthweight group

p=0.92 p=0.26 p=0.16

1410115107 42 43

400-599g600-899g900-999g


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

Comparison of Total Score DQ disclose or Conflicts of Interest (COIs) to resolve.-categorized by G.W.

p=0.042 p=0.06 p=0.06

12 9101 88 67 72

22-23W24-26W27W-


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

22 disclose or Conflicts of Interest (COIs) to resolve.-23wBaseline Characteristics

Mean±SD


Better developmental function at 3 years for infants born at 22 23wks who participated in the randomized controlled tria

  • Conclusions: disclose or Conflicts of Interest (COIs) to resolve.

  • 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.


Disclosure statement speaker shinya hirano
DISCLOSURE STATEMENT disclose or Conflicts of Interest (COIs) to resolve.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.


Unapproved or off label disclosures for insert name
Unapproved or Off Label disclose or Conflicts of Interest (COIs) to resolve.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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