NCT04239508

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
300mo left

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jan 2000Dec 2050

Study Start

First participant enrolled

January 1, 2000

Completed
20.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
30.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2050

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

51 years

First QC Date

January 20, 2020

Last Update Submit

June 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

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

Eligibility Criteria

Age0 Days - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

see cohort descriptions under 'Groups and Interventions'

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neonatology

Zurich, 8091, Switzerland

RECRUITING

Related Links

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Mark Adams, PhD

CONTACT

Dirk Bassler, MD, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Years
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 27, 2020

Study Start

January 1, 2000

Primary Completion (Estimated)

December 31, 2050

Study Completion (Estimated)

December 31, 2050

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations