UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027794
Receipt number R000031834
Scientific Title Research on a monitoring system for maintaining high quality of Early Essential Newborn Care in the Western Pacific Region
Date of disclosure of the study information 2017/07/01
Last modified on 2020/03/24 16:30:07

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Basic information

Public title

Research on a monitoring system for maintaining high quality of Early Essential Newborn Care in the Western Pacific Region

Acronym

Research on continuous quality improvement of newborn care

Scientific Title

Research on a monitoring system for maintaining high quality of Early Essential Newborn Care in the Western Pacific Region

Scientific Title:Acronym

Research on continuous quality improvement of newborn care

Region

Japan Asia(except Japan)


Condition

Condition

Newborn death

Classification by specialty

Pediatrics Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

While the under-five child mortality was successfully declined in last 20 years, the neonatal mortality had not seen a dramatic reduction. WHO Western Pacific Regional Office(WPRO) developed the Early Essential Newborn Care(EENC) as a simple and cost-effective measures to prevent newborn deaths by changing routinely implemented harmful practices. Lao People's Democratic Republic(Lao PDR) with the highest neonatal mortality rate (27.2 newborn deaths per 1,000 births) in the region adopted EENC in 2015 and committed to roll out it to district hospitals in 2017.
However, mere introduction of EENC cannot reduce newborn deaths unless EENC is routinely provided for every newborn with high quality. Frequent interim training or external supervision are commonly implemented but are not feasible in resource limited settings. It has been observed that there is little continuous effort to solve detected problems after supervision. To overcome the above mentioned issues, it was agreed to introduce a self-managed continuous monitoring on EENC quality in Lao PDR. This study aims to evaluate the effectiveness of a self-monitoring on promotion of behavior change, retention of knowledge and skills on EENC, and inform how to design a feasible and sustainable system in resource limited countries. We believe that building a system to maintain quality of EENC will contribute to reduction of the neonatal mortality.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Likelihood of practicing EENC among health staff.
The data will be collected six times during the study period: 1) before the EENC coaching, 2) before randomization, 3) three months after randomization, 4) six months after randomization, 5) nine months after randomization, 6) one year after randomization. Likelihood of behaviour is quantified by using a self-administered questionnaire that is developed based on the Planned behavior theory(Ajzen, 1991). There are 48 questions in total and each question has scale between 1 to 7.

Key secondary outcomes

1.Knowledge on EENC among health staff
The data will be collected three times during the study period: 1) before the EENC coaching, 2) before randomization, and 3) one year after randomization.

2.Skill on EENC among health staff
The data will be collected twice during the study period: 1) before randomization and 2) one year after randomization.
We will use a written and simulation tests to evaluate and quantify the level of knowledge and skills on EENC.

3.Hospital environmental changes facilitating implementation of EENC
The data will be collected twice in both groups during the study period: 1) before randomisation and 2) one year after randomisation by the provincial officials. We will use a checklist designed by the Lao MoH and the WHO to quantify the district hospital's level of commitment and the availability of essential equipment, commodities, medications and human resources in each facility.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

A self-managed continuous monitoring for maintaining quality of Early Essential Newborn Care (EENC)

Interventions/Control_2

An external supervision visit

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

15 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Obstetricians, pediatricians, general doctors, assistant doctors, midwives, nurses and other types of health staff who are routinely involved in the maternity and newborn care and have received the EENC coaching in district hospitals of the two target provinces.

Key exclusion criteria

Those who are going to leave the current working place or retire within one year.

Target sample size

225


Research contact person

Name of lead principal investigator

1st name Sayaka
Middle name
Last name Horiuchi

Organization

Teikyo University

Division name

Graduate School of Public Health

Zip code

173-8605

Address

2-11-1, Kaga, Itabashi, Tokyo, Japan

TEL

03-3964-1211(46215)

Email

sayakah@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name Sayaka
Middle name
Last name Horiuchi

Organization

Teikyo university

Division name

Graduate School of Public Health

Zip code

173-8605

Address

2-11-1, Kaga, Itabashi, Tokyo, Japan

TEL

09026240872

Homepage URL


Email

sayakah@med.teikyo-u.ac.jp


Sponsor or person

Institute

Teikyo University

Institute

Department

Personal name



Funding Source

Organization

Teikyo University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

World Health Organization, Laos Country Office

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Teikyo University

Address

2-11-1 Kaga, Itabashi-ku, Tokyo, Japan

Tel

03-3964-7256(42203)

Email

turb-office@teikyo-u.ac.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

2017 Year 07 Month 01 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

198

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

2017 Year 07 Month 19 Day

Date of IRB

2017 Year 07 Month 18 Day

Anticipated trial start date

2017 Year 07 Month 20 Day

Last follow-up date

2019 Year 04 Month 05 Day

Date of closure to data entry

2019 Year 05 Month 17 Day

Date trial data considered complete

2019 Year 06 Month 01 Day

Date analysis concluded

2019 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 06 Month 17 Day

Last modified on

2020 Year 03 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031834


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name