Swiss Neonatal Network & Follow-up Group

Recruiting

• Conditions: Very Low Birth Weight Infant; Very Preterm Maturity of Infant; Asphyxia Neonatorum

• Registration Number: NCT04239508
• Lead Sponsor: Swiss Neonatal Network

Brief Summary

The chief aim of the Swiss Neonatal Network \& Follow-Up Group (SwissNeoNet) is to maintain and / or improve the quality and safety of medical care for high-risk newborn infants and their families in Switzerland through a coordinated program of research, education and collaborative audit. In support of its aim, SwissNeoNet hosts the official medical quality register for the Swiss level III and level IIB units. Participation for these units is mandatory according to the intercantonal declaration for Highly Specialized Medicine (HSM) of September 22, 2011 and the Society's Standards for Levels of Neonatal Care in Switzerland.

Detailed Description

Inaugurated in 1995, SwissNeoNet now routinely collects data from 9 level III, 10 level IIB and 14 neuro-/developmental pediatric units encompassing information about the care and outcomes of high-risk newborn infants. Data collection is monitored for population coverage, dataset completeness, plausibility and reliability. Data quality is audited within a three year cycle.

Quality improvement

SwissNeoNet releases an annual quality report for participating centers encompassing up to 20 process- and outcome quality indicators. It annually collects data on unit infrastructure evaluated by the Committee for the Accreditation of Neonatology Units (CANU). To discuss quality issues and educational purposes, it hosts bi-annual meetings/symposia for the NEO Directors Group and the Follow-up Group, respectively. The SwissNeoNet member platform offers tools for unit-to-unit quality improvement collaboration (mailing lists, event-organizer, forum, file-sharing and survey builder).

Research

SwissNeoNet coordinates cross-sectional and longitudinal cohort studies that are performed by local researchers using SwissNeoNet's prospectively collected data. These studies focus on mortality, morbidity and/or long-term outcome issues and the analysis of risk factors for development. The network disseminates its research in scientific articles in peer reviewed medical journals.

Support

SwissNeoNet supports the units logistically to ensure that each patient receives primary care (NICU bed availability) and follow-up assessments at 9 to 12 months corrected, 18 to 24 months corrected, and at 5.5 to 6 years of age (FU missing lists) to ensure early diagnosis and intervention. With regards to its Follow-up program, the SwissNeoNet also supports training of new staff and coordinates the launch of new testing instruments between centers.

Study Timeline

• Study Start: 2000-01-01
• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Primary Completion: 2050-12-31
• Study Completion: 2050-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	0 to 6 years	Mortality in delivery room, during primary hospitalization or within first 6 years of life
Major morbidities of newborns	0 to 6 years	Period prevalences (i.e. incident proportions per year or period of years) of intraventricular hemorrhages, necrotizing enterocolitis, sepsis, retinopathy of prematurity, bronchopulmonary displasia, neurodevelopmental impairment at 2 or 6 years, and other

Trial Locations

Locations (1)

Department of Neonatology; 🇨🇭 Zürich, Switzerland