UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023096 |
|---|---|
| Receipt number | R000025811 |
| Scientific Title | Analgesic effect of 12 % versus 24 % of sucrose for analgesia during heel lance in newborn infants |
| Date of disclosure of the study information | 2016/07/12 |
| Last modified on | 2020/08/29 15:55:33 |
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Basic information
Public title
Analgesic effect of 12 % versus 24 % of sucrose for analgesia during heel lance in newborn infants
Acronym
Evaluation of analgesic effect of sucrose in newborn infants
Scientific Title
Analgesic effect of 12 % versus 24 % of sucrose for analgesia during heel lance in newborn infants
Scientific Title:Acronym
Evaluation of analgesic effect of sucrose in newborn infants
Region
| Japan |
Condition
Condition
a neanate
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of sucrose for analgesia in newborn infants during heel lance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of the median of the Premature Infant Pain Profile (PIPP) score between 24 % oral sucrose and 12 % oral sucrose during heel lance: a double blind randomized trial
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
24%-sucrose group
Interventions/Control_2
12%-sucrose group
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
| 8 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Infants who are less than 8 days after birth between 35 and 42 weeks of corrected age, and are hospitalized at the NICU in Tokyo Women's Medical University Hospital
Infants who were enrolled after informed consent was obtained from their parents
Infants whose legal guardians have fully understood after having received sufficient explanation about participation in this study and have given written consent at their free will
Infants were enrolled if informed consent was obtained from at least 1 parent who had problems such as a single mother, perinatal death of a mother, and so on
Key exclusion criteria
Infants with congenital anomalies of intestines
Infants with chromosomal anomalies
Infants with multiple anomaly syndrome
Infants with hyperglycemia who need insulin administration
Infants whom the principal researcher has judged to be inappropriate as subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Shiraishi |
Organization
Tokyo Woman's Medical University Hospital
Division name
kango-bu
Zip code
162-0054
Address
Tokyo sinnjuku-ku kawada-cho 8-1
TEL
03-3353-8111
ssakamoto@dons.twmu.ac.jp
Public contact
Name of contact person
| 1st name | Chizuru |
| Middle name | |
| Last name | Matsumoto |
Organization
Tokyo Woman's Medical University Hospital
Division name
kango-bu
Zip code
162-0054
Address
Tokyo sinnjuku-ku kawada-cho 8-1
TEL
03-3353-8111
Homepage URL
poccpy@yahoo.co.jp
Sponsor or person
Institute
Tokyo Woman's Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Woman's Medical University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Woman's Medical University Hospital
Address
Tokyo sinnjuku-ku kawada-cho 8-1
Tel
03-3380-6564
poccpy@yahoo.co.jp
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
| 2016 | Year | 07 | Month | 12 | 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
| 2016 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 10 | Day |
Last modified on
| 2020 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025811
