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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035536
Receipt No. R000022621
Scientific Title Pilot study to explore additional indication of therapeutic hypothermia for neonates
Date of disclosure of the study information 2019/01/14
Last modified on 2019/01/14

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Basic information
Public title Pilot study to explore additional indication of therapeutic hypothermia for neonates
Acronym Additional indication of hypothermia for neonates
Scientific Title Pilot study to explore additional indication of therapeutic hypothermia for neonates
Scientific Title:Acronym Additional indication of hypothermia for neonates
Region
Japan

Condition
Condition Neonatal encephalopathy
Classification by specialty
Neurology Obsterics and gynecology Pediatrics
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the safety of moderate systemic hypothermia for 72 hours in neonates who are either slightly (i) less matured (33-35 weeks), (ii) less severely asphyxiated, (iii) mildly encephalopathic, or (iv) older (6-12 hours) than those cooled in previous phase-III trials.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Death or severe adverse events until hospital discharge
Key secondary outcomes Days on mechanical ventilation
Age at hospital discharge
Requirement for tube-feeding at discharge
Death or moderate disability (Time Frame: Birth to 18-22 months corrected age)
Brain MRI findings (Time Frame: 5-14 days)

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Other
Interventions/Control_1 Induced whole-body cooling with a target core body temoerature of 33.5C for 72 hours
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
1 days-old <=
Age-upper limit
1 days-old >=
Gender Male and Female
Key inclusion criteria Neonates are first assessed using the standard criteria for therapeutic hypothermia* (Shankaran et al. NEJM 2005).

1. Neonates born at 36 weeks gestation or greater, and body weight >1799g
2. Postnatal age < 6 hours after birth
3. At least one of the following criteria:
- Apgar score 0-5 at 10 minutes
- Cord or first postnatal blood pH less than 7.0
- Cord or first postnatal blood Base deficit greater than 16 mEq/L
- Need for continued resuscitation at least 10 minutes
4. Abnormal neurological exam suggesting the presence of moderate or severe encephalopathy

Neonates who meet 3 of 4 criteria are assessed for eligibility using the following entry criteria.

Category 1: Neonates < 36 weeks gestation but > 33 0/7 weeks, and/or body weight between 1500g and 1799g.
Category 2: Neonates between 6 and 12 hours of birth when cooling is initiated.
Category 3: At least one of the following criteria:
- Apgar 0-5 at 5 minutes
- pH less than 7.1
- Base deficit greater than 10 mEq/L
Category 4: Abnormal neurological exam suggesting the presence of mild encephalopathy
Key exclusion criteria Gestational age <33 weeks or body weight <1500g.
Older than 12 hours of birth.
Neonates deemed inappropriate for cooling because of critical clinical conditions, such as severe haemorrhagic diathesis, congenital malformations, infection and cardiopulmonary failure.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osuke Iwata
Organization Kurume University School of Medicine
Division name Dept of Paediatrics
Zip code
Address 67 Asahimachi, Kurume, Fukuoka, 830-0011 Japan
TEL 0942-35-3311
Email oiwata@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kennosuke Tsuda
Organization Yokohama City University Medical Center
Division name Pediatrics
Zip code
Address 4-57 Urafune, Minami, Yokohama, Kanagawa, Japan
TEL 045-261-5656
Homepage URL
Email kentsuda1222@hotmail.co.jp

Sponsor
Institute Kurume University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Committee on Resuscitation, Japan Society of Perinatal and Neonatal Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
2018 Year 12 Month 01 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 01 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 01 Month 14 Day
Last modified on
2019 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022621

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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