UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000526 |
|---|---|
| Receipt number | 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 10:07:30 |
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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
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
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000638
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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