UMIN-CTR Clinical Trial

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
Email	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
Email	poccpy@yahoo.co.jp

Sponsor
Institute	Tokyo Woman's Medical University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025811