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Improvement of NICU practice and team approach cluster randomaized controlled trial

Improvement of NICU practice and team approach cluster randomaized controlled trial - INTACT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007064
Enrollment
2800
Registered
2012-02-01
Start date
2012-02-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very low birth weight infants

Interventions

Workshop and outreach education with 2 clinical guidelines selceted according to the analysis of each participating hospital background data resgistered 3 years prior to the intervention control

Sponsors

Tokyo Women's Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Very low birht weight infants with birth weight between 400 and 1500g admitted on day 0

Exclusion criteria

Exclusion criteria: Still birth

Design outcomes

Primary

MeasureTime frame
intact survival at 3 years of age

Secondary

MeasureTime frame
mortality at day 28 after birth mortality at 1 year of age mortality at 1.5 year age intact survival at 1.5 year of age neurological development at 1.5 year of age mortality at 3 year of age neurological development at 3 year of age morbilities during admission (related guideline, non-related) Process indicator related guideline and intervention Quality of Life <Medical staff> Oeganization cluture scale In organization human relationship scale Occupational Satisfaction SPRAT scale Occupational Stress Burnout scale Office hours

Countries

Japan

Contacts

Public ContactToshihiko Nishida

National Center for Child Health and Development INTACT support office, Department of Health Policy

nishida-t@ncchd.go.jp03-3416-0181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026