Very Low Birth Weight InfantSwissNeoNetNCT04239508
Swiss Neonatal Network & Follow-up Group
An observational study of Very Low Birth Weight Infant and Very Preterm Maturity of Infant, run by Swiss Neonatal Network at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Very Low Birth Weight Infant, Very Preterm Maturity of Infant, Asphyxia Neonatorum
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2000to 31 Dec 2050
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: see cohort descriptions under 'Groups and Interventions'
Who may be able to join
- All Swiss live-born infants below 32 weeks gestational age or 1501g birth weight
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dirk Bassler, MD, MSc contact
Switzerland1 site, 1 recruiting
- Recruiting
Department of Neonatology
Zurich, 8091
Mark Adams, PhD, +41432533034, mark.adams@usz.ch
About this study
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.
Read the 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.
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality in delivery room, during primary hospitalization or within first 6 years of life
Measured: 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
Measured: 0 to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jan 2000
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Birth Weight InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Swiss Neonatal Network
- Sponsor type
- Research network
- Collaborators
- Department of Neonatology, Children's Clinic, Cantonal Hospital Aarau, Switzerland, Department of Neuropaediatrics, Children's Clinic, Cantonal Hospital Aarau, Switzerland, University Children's Hospital Basel, 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, University of Lausanne Hospitals, University Hospital, Geneva, Neonatal and Paediatric Intensive Care Unit, Children's Hospital of Lucerne, Switzerland, Department of Pediatrics, Cantonal Hospital Muensterlingen, Switzerland, Department of Pediatrics, Cantonal Hospital Neuchatel, Switzerland, Cantonal Hospital of St. Gallen, 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239508
- Sponsor's protocol ID
- PB_2016-02299
- Acronym
- SwissNeoNet
- Status last verified
- Jun 2025
- First submitted
- 20 Jan 2020
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Neonatal Network & Follow-up Group
- ClinicalTrials.gov ID
- NCT04239508
- Acronym / sponsor ID
- SwissNeoNet / PB_2016-02299
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Swiss Neonatal NetworkResearch network
- Collaborators
- Department of Neonatology, Children's Clinic, Cantonal Hospital Aarau, Switzerland, Department of Neuropaediatrics, Children's Clinic, Cantonal Hospital Aarau, Switzerland, University Children's Hospital Basel, 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, University of Lausanne Hospitals, University Hospital, Geneva, Neonatal and Paediatric Intensive Care Unit, Children's Hospital of Lucerne, Switzerland, Department of Pediatrics, Cantonal Hospital Muensterlingen, Switzerland, Department of Pediatrics, Cantonal Hospital Neuchatel, Switzerland, Cantonal Hospital of St. Gallen, 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
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- see cohort descriptions under 'Groups and Interventions'
Key inclusion criteria (4 listed)
- All Swiss live-born infants below 32 weeks gestational age or 1501g birth weight
- All Swiss live-born infants between 32 0/1 and 33 6/7 weeks gestational age that are above 1500g birth weight
- Infants between 35 0/7 and 42 6/7 weeks' gestational age with moderate or severe encephalopathy due to perinatal asphyxia
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 0 to 6 years
Mortality in delivery room, during primary hospitalization or within first 6 years of life
Major morbidities of newborns
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- SwissNeoNet descriptionLink provided by the sponsor.
- SwissNeoNet publicationsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dirk Bassler, MD, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Very Low Birth Weight Infant and Very Preterm Maturity of Infant, run by Swiss Neonatal Network at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Adams, PhD (+41432533034, mark.adams@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 0 to 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.