UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031834