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

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 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


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

Value
https://center6.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