SwissNeoNet: Swiss Neonatal Network & Follow-up Group

Sponsor

Swiss Neonatal Network (Other)

Overall Status

Recruiting

CT.gov ID

NCT04239508

Collaborator

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

1,000

Enrollment

Location

612

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Very Low Birth Weight Infant Very Preterm Maturity of Infant Asphyxia Neonatorum

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Swiss Neonatal Network & Follow-up Group

Actual Study Start Date :

Jan 1, 2000

Anticipated Primary Completion Date :

Dec 31, 2050

Anticipated Study Completion Date :

Dec 31, 2050

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Days to 28 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neonatology	Zürich		Switzerland	8091

Sponsors and Collaborators

Swiss Neonatal Network
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
University Hospital, Zürich
University Children's Hospital, Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Swiss Neonatal Network

ClinicalTrials.gov Identifier:

NCT04239508

Other Study ID Numbers:

PB_2016-02299

First Posted:

Jan 27, 2020

Last Update Posted:

May 9, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Asphyxia Neonatorum

Birth Weight

Asphyxia

Study Results

No Results Posted as of May 9, 2022