Clinical trial NCT04239508: Swiss Neonatal Network & Follow-up Group
Official title: Swiss Neonatal Network & Follow-up Group
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Very Low Birth Weight Infant
Very Preterm Maturity of Infant
Asphyxia Neonatorum
Lead sponsor: Swiss Neonatal Network
Sponsor class: NETWORK
Collaborators: name: Department of Neonatology, Children's Clinic, Cantonal Hospital Aarau, Switzerland
name: Department of Neuropaediatrics, Children's Clinic, Cantonal Hospital Aarau, Switzerland
name: Department of Neonatology, University of Basel Children's Hospital (UKBB), Switzerland
name: Department of Neuropaediatrics and Developmental Medicine, University of Basel Children's Hospital (UKBB), Switzerland
name: Department of Pediatrics, San Giovanni Hospital Bellinzona, Switzerland
name: Department of Neonatology, University Hospital Berne, Switzerland
name: Department of Neuropaediatrics, University Hospital Berne, Switzerland
name: Development and Pediatric Neurorehabilitation Center, Biel, Switzerland
name: Department of Neonatology, Children's Hospital Chur, Switzerland
name: Department of Neuropaediatrics, Children's Hospital Chur, Switzerland
name: Department of Neuropediatrics, Cantonal Hospital Fribourg, Switzerland
name: University of Lausanne Hospitals
name: Department of Neonatology, University Hospital Geneva (HUG), Switzerland
name: Division of Development and Growth, University Hospital Geneva (HUG), Switzerland
name: Neonatal and Paediatric Intensive Care Unit, Children's Hospital of Lucerne, Switzerland
name: Department of Neuropaediatrics, Children's Hospital of Lucerne, Switzerland
name: Department of Pediatrics, Cantonal Hospital Muensterlingen, Switzerland
name: Department of Pediatrics, Cantonal Hospital Neuchatel, Switzerland
name: Department of Neonatology, Cantonal Hospital St. Gallen, Switzerland
name: Neonatal and Paediatric Intensive Care Unit, Children's Hospital St. Gallen, Switzerland
name: Department of Child Development, Children's Hospital St. Gallen, Switzerland
name: Department of Neonatology, Cantonal Hospital Winterthur, Switzerland
name: Social Pediatrics Center, Cantonal Hospital Winterthur, Switzerland
name: University Hospital, Zürich
name: University Children's Hospital, Zurich
First posted: 2020-01-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: see cohort descriptions under 'Groups and Interventions'

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 0 to 6 years
measure: Major morbidities of newborns
timeFrame: 0 to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Department of Neonatology
Study officials:
References: