Swiss Neonatal Network & Follow-up Group

Very Low Birth Weight Infant Clinical Trial

— SwissNeoNet  

Official title:

Swiss Neonatal Network & Follow-up Group

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04239508
• Other study ID #: PB_2016-02299
• Status: Recruiting
• Start date: January 1, 2000
• Est. completion date: December 31, 2050

Study information

• Verified date: November 2023
• Source: Swiss Neonatal Network
• Contact: Mark Adams, PhD
• Phone: +41432533034
• Email: mark.adams[@]usz.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2050
• Est. primary completion date: December 31, 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Weight
• Very Low Birth Weight Infant
• Very Preterm Maturity of Infant

Locations

Country	Name	City	State
Switzerland	Department of Neonatology	Zürich

Sponsors (27)

Lead Sponsor

Collaborator

Swiss Neonatal Network

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

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality in delivery room, during primary hospitalization or within first 6 years of life	0 to 6 years
Primary	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

External Links

•   SwissNeoNet description
•   SwissNeoNet publications