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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027794
Receipt No. 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 2019/06/19

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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
Middle name
Last name Sayaka Horiuchi
Organization Teikyo University
Division name Graduate School of Public Health
Zip code
Address 2-11-1, Kaga, Itabashi, Tokyo
TEL 03-3964-1211(46215)
Email sayakah@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sayaka Horiuchi
Organization Teikyo University
Division name Graduate School of Public Health
Zip code
Address 2-11-1, Kaga, Itabashi, Tokyo
TEL 03-3964-1211(46215)
Homepage URL
Email sayakah@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

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
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
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
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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 17 Day
Last modified on
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.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


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