UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022983 |
|---|---|
| Receipt number | R000026495 |
| Scientific Title | Analgesic effect of expressed breast milk in combination with a pacifier for newborn receiving heel lance : A randomized control trial. |
| Date of disclosure of the study information | 2016/07/02 |
| Last modified on | 2016/11/09 10:01:49 |
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Basic information
Public title
Analgesic effect of expressed breast milk in combination with a pacifier for newborn receiving heel lance : A randomized control trial.
Acronym
Analgesic effect of expressed breast milk in combination with a pacifier for newborn receiving heel lance.
Scientific Title
Analgesic effect of expressed breast milk in combination with a pacifier for newborn receiving heel lance : A randomized control trial.
Scientific Title:Acronym
Analgesic effect of expressed breast milk in combination with a pacifier for newborn receiving heel lance.
Region
| Japan |
Condition
Condition
Newborn
Classification by specialty
| Pediatrics | Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of expressed breast milk in combination with a pacifier on pain responses in newborn undergoing heel lance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A Japanese Version of the Premature Infant Pain Profile
Key secondary outcomes
Heart Rate Variability
Crying time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
2ml of expressed breast milk combined with a pacifier group
Interventions/Control_2
2ml of expressed breastmilk group
Interventions/Control_3
A pacifier group
Interventions/Control_4
No intervention(control) group
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 5 | days-old | <= |
Age-upper limit
| 6 | days-old | > |
Gender
Male and Female
Key inclusion criteria
1. Born between 37 and 42 weeks' gestational age.
2.Informed consent to participate to the study is obtained from the mothers.
Key exclusion criteria
Infants meet the exclusion criteria which is described below are excluded
1. The case of birth by emergency cesarean section.
2.Apgar score <7 (5 minites).
3.Infants with complication.
4.Infant who has been given an analgesic.
5. The case that the chief doctor judged inappropriate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Jono |
Organization
Tokai University
Division name
School of Health Science,Nursing Department
Zip code
Address
143 Shimokasuya,Isehara,Kanagawa,259-1193, Japan
TEL
0463-93-1121
jono@tokai-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Toyama |
Organization
Graduate school of Tokai University
Division name
Health science
Zip code
Address
143 Shimokasuya,Isehara,Kanagawa, 259-1193,Japan
TEL
0463-93-1121
Homepage URL
5bmnm006@mail.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University, Graduate School of Health Sciences.
Institute
Department
Personal name
Funding Source
Organization
Tokai University, Graduate School of Health Sciences.
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
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
| 2016 | Year | 07 | Month | 02 | 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 | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 02 | Day |
Last modified on
| 2016 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026495
