Swiss Neonatal Network & Follow-up Group (SwissNeoNet)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Mark Adams, PhD; Phone Number: +41432533034; Email: mark.adams@usz.ch
• Study Contact Backup: Name: Dirk Bassler, MD, MSc; Email: dirk.bassler@usz.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • Recruiting
    • Department of Neonatology
    • Contact: Mark Adams, PhD; Phone Number: +41432533034; Email: mark.adams@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 weeks (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

see cohort descriptions under 'Groups and Interventions'

Description

Inclusion criteria of "Minimal Neonatal Dataset" (MNDS):

All Swiss live-born infants below 32 weeks gestational age or 1501g birth weight

Inclusion criteria of "Below 34 data collection", (B34):

All Swiss live-born infants between 32 0/1 and 33 6/7 weeks gestational age that are above 1500g birth weight

Inclusion criteria of "Swiss Asphyxia and Cooling Registry", (ASP):

Infants between 35 0/7 and 42 6/7 weeks' gestational age with moderate or severe encephalopathy due to perinatal asphyxia

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Minimal Neonatal Dataset MNDS; All Swiss live-born infants below 32 weeks gestational age or 1501g birth weight
Below 34, B34; All Swiss live-born infants between 32 0/1 and 33 6/7 weeks gestational age that are above 1500g birth weight
Swiss Asphyxia and Cooling Registry, ASP; Infants between 35 0/7 and 42 6/7 weeks' gestational age with moderate or severe encephalopathy due to perinatal asphyxia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality in delivery room, during primary hospitalization or within first 6 years of life	0 to 6 years
Major morbidities of newborns	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	0 to 6 years

Collaborators and Investigators

• Sponsor: Swiss Neonatal Network
• Collaborators: University Children's Hospital, Zurich; University Hospital, Zürich; Department of Neonatology, Children's Clinic, Cantonal Hospital Aarau, Switzerland; Department of Neuropaediatrics, Children's Clinic, Cantonal Hospital Aarau, Switzerland; Department of Neonatology, University of Basel Children's Hospital (UKBB), Switzerland; Department of Neuropaediatrics and Developmental Medicine, University of Basel Children's Hospital (UKBB), Switzerland; Department of Pediatrics, San Giovanni Hospital Bellinzona, Switzerland; Department of Neonatology, University Hospital Berne, Switzerland; Department of Neuropaediatrics, University Hospital Berne, Switzerland; Development and Pediatric Neurorehabilitation Center, Biel, Switzerland; Department of Neonatology, Children's Hospital Chur, Switzerland; Department of Neuropaediatrics, Children's Hospital Chur, Switzerland; Department of Neuropediatrics, Cantonal Hospital Fribourg, Switzerland; Department of Neonatology, University Hospital Lausanne (CHUV), Switzerland; Department of Child Development, University Hospital Lausanne (CHUV), Switzerland; Department of Neonatology, University Hospital Geneva (HUG), Switzerland; Division of Development and Growth, University Hospital Geneva (HUG), Switzerland; Neonatal and Paediatric Intensive Care Unit, Children's Hospital of Lucerne, Switzerland; Department of Neuropaediatrics, Children's Hospital of Lucerne, Switzerland; Department of Pediatrics, Cantonal Hospital Muensterlingen, Switzerland; Department of Pediatrics, Cantonal Hospital Neuchatel, Switzerland; Department of Neonatology, Cantonal Hospital St. Gallen, Switzerland; Neonatal and Paediatric Intensive Care Unit, Children's Hospital St. Gallen, Switzerland; Department of Child Development, Children's Hospital St. Gallen, Switzerland; Department of Neonatology, Cantonal Hospital Winterthur, Switzerland; Social Pediatrics Center, Cantonal Hospital Winterthur, Switzerland

Publications and helpful links

Helpful Links

• SwissNeoNet description
• SwissNeoNet publications

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Estimated): December 31, 2050
• Study Completion (Estimated): December 31, 2050

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Infant, Newborn, Diseases; Body Weight; Death; Birth Weight; Asphyxia; Asphyxia Neonatorum
• Other Study ID Numbers: PB_2016-02299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No