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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022983
Receipt No. 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

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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
Email 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
Email 5bmnm006@mail.u-tokai.ac.jp

Sponsor
Institute Tokai University, Graduate School of Health Sciences.
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026495

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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