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Recruitment status Completed
Unique ID issued by UMIN UMIN000008125
Receipt No. R000009566
Scientific Title A randomized controlled trial of sterile distilled water and/or pacifier as analgesic for newborns undergoing venipuncture
Date of disclosure of the study information 2012/06/08
Last modified on 2012/06/08

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Basic information
Public title A randomized controlled trial of sterile distilled water and/or pacifier as analgesic for newborns undergoing venipuncture
Acronym A randomized controlled trial of water and/or pacifier as analgesic for newborns
Scientific Title A randomized controlled trial of sterile distilled water and/or pacifier as analgesic for newborns undergoing venipuncture
Scientific Title:Acronym A randomized controlled trial of water and/or pacifier as analgesic for newborns
Region
Japan

Condition
Condition Healthy newborns
Classification by specialty
Nursing Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to examine whether sterile distilled water and/or pacifier interventions have marked analgesic effects on venipuncture sampling involving newborns who cannot receive sucrose.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Duration of first cry after venipuncture, the duration of crying and Premature Infant Pain Profile (PIPP) were measured 11 times at 30-second intervals from sampling initiation.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Food Other
Interventions/Control_1 2 ml of 24% sucrose solution followed by pacifier
Interventions/Control_2 2 ml of sterile distilled water followed by pacifier
Interventions/Control_3 Pacifier alone
Interventions/Control_4 2 ml of 24% sucrose solution
Interventions/Control_5 No intervention (control)
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit
0 weeks-old >
Gender Male and Female
Key inclusion criteria Healthy neonates,
36 weeks or older gestational age and Apgar score of 7 at 1 or 5 minutes.
Key exclusion criteria Exclusion criteria for participants were as follows: at-risk pregnancy, medical instability, birth under general anesthesia, maternal use of opioids, administration of naloxone or phenobarbital in the previous 48 hours, and artificial feeding.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroko Uematsu
Organization Takamatsu Red Cross Hospital
Division name Nursing department
Zip code
Address 4-1-3Bancho,Takamatsu City,Kagawa Prefecure,760-0017,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Uematsu
Organization Takamatsu Red Cross Hospital
Division name Nursing department
Zip code
Address
TEL
Homepage URL
Email d126673@hiroshima-u.ac.jp

Sponsor
Institute Takamatsu Red Cross Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Own expense
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 06 Month 08 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
During the 30 seconds after puncture,  both cry time and PIPP were  significantly less in the groups with  24% sucrose solution followed by pacifier, sterile distilled water  followed by pacifier, and pacifier alone compared with those in the no intervention group. Duration of first cry after venipuncture was significantly shorter in the groups with 24% sucrose solution followed by pacifier, sterile distilled water followed by pacifier, and pacifier alone than that in the control group.
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
2009 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 05 Month 01 Day
Date trial data considered complete
2010 Year 05 Month 01 Day
Date analysis concluded
2010 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 06 Month 08 Day
Last modified on
2012 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009566


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