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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000526
Receipt No. R000000638
Scientific Title Establishment of evidences for usage of sedative drugs in neonates and children: Evaluation of the dosage, efficacy, and safety of midazolam.
Date of disclosure of the study information 2006/11/22
Last modified on 2009/11/24

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Basic information
Public title Establishment of evidences for usage of sedative drugs in neonates and children: Evaluation of the dosage, efficacy, and safety of midazolam.
Acronym Evaluation of the dosage, efficacy, and safety of midazolam.
Scientific Title Establishment of evidences for usage of sedative drugs in neonates and children: Evaluation of the dosage, efficacy, and safety of midazolam.
Scientific Title:Acronym Evaluation of the dosage, efficacy, and safety of midazolam.
Region
Japan

Condition
Condition Mechanically ventilated neonates and children.
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy, safety, and pharmaco-dynamics of midazolam.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Success rate for sedation with midazolam in evaluating sedative state by Ramsay sedation score
Key secondary outcomes Adverse event/Pharmacokinetics

Base
Study type Interventional

Study design
Basic design Single arm
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
Medicine
Interventions/Control_1 Midazolam
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

Not applicable
Age-upper limit
15 years-old >
Gender Male and Female
Key inclusion criteria Mechanically ventilated neonates and children are included:
1) whose post-conceptional age are between 23 weeks and 15 years old,
2) who are obtained informed consent.

Key exclusion criteria Neonates and children are excluded:
1) who are given paralyzing and sedative drugs continuously.
2) who are given the drugs listed on the drugs do not use.
3) who have severe congenital malformation and chromosomal anomaly.
4) who have neurological disease (ex. severe neonatal asphyxia, severe central nerve impairment, and congenital metabolic diseases) by which it is difficult to evaluate the sedative state.
5) who have severe liver dysfunction, or renal dysfunction.
6) who have hyper reactivity to midazolam and other drugs.
7) who have acute glaucoma.
8) who have severe myasthenia gravis.
9) who are given HIV protease inhibitor, or HIV reverse transcriptase inhibitor.
10) who have alcoholism with shock, come, and depressed vital sign.
11) who have already attended to this study.
12) who are diagnosed not suitable for this study by attending doctors because of their psychological or social factors.
13) who are diagnosed not suitable for this study by attending doctors
14) whose parents change their mind and want not to attend to this study afterward.
15) who are given midazolam by bolus intravenous injection only.
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yushi Itoh ,MD
Organization National Center for Child Health and Development
Division name Division of Neonatology, Department of Perinatology and Maternal Care.
Zip code
Address 2-10-1 Okura,Setakgaya-ku tokyo 157-8535 Japan
TEL 03-3416-0181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yushi Itoh ,MD
Organization National Center for Child Health and Development
Division name Division of Neonatology, Department of Perinatology and Maternal Care.
Zip code
Address 2-10-1 Okura,Setakgaya-ku tokyo 157-8535 Japan
TEL 03-3416-0181
Homepage URL
Email

Sponsor
Institute Health and Labour Science Research Grants for Clinical Research on Pediatric disease(Evaluation of the dosage, efficacy, and safety of midazolam)study groups.
Institute
Department

Funding Source
Organization Health and Labour Science Research Grants for Clinical Research on Pediatric disease
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2006 Year 11 Month 22 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
2006 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 06 Month 01 Day
Date trial data considered complete
2009 Year 09 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 11 Month 22 Day
Last modified on
2009 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000638

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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