Neurodevelopmental AbnormalitySwissORCHIDNCT05996211
The Swiss Neurodevelopmental Outcome Registry for Children With CHD
An observational study of Neurodevelopmental Abnormality and Congenital Heart Disease, run by University Children's Hospital, Zurich at 3 sites in Switzerland.
Trial summary
Introduction: Congenital heart disease (CHD) is the most frequent birth defect. As survival has significantly improved, attention has turned to neurodevelopmental outcomes of children undergoing heart surgery in early infancy. Read more about this study
- Who is it for?
- Ages 1 week to 6 weeks
- Conditions the study is for
- Neurodevelopmental Abnormality, Congenital Heart Disease, Cardiac Disease
- How many people
- 1,000 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 1 Jan 2019to 31 Dec 2032
- How long will I take part?
- 10 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 1 week to 6 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Patients with severe CHD
Who may be able to join
- Neonates (including preterm born children) with severe CHD
- Requiring an invasive cardiac intervention (including heart-lung-machine) within the first 6 weeks of life.
Who cannot join
- Neonates (including preterm born children) with simple CHD
- Requiring simple cardiac surgery or catheter intervention such as closure of patent arterial duct or simple repair of aortic coarctation without heart-lung-machine and low impact on neurodevelopmental outcome.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites, 3 recruiting
- Recruiting
University of Bern
Bern
Damian Hutter, MD, damian.hutter@insel.ch
Walter H Knirsch, MD, +41442667617, walter.knirsch@kispi.uzh.ch
- Recruiting
University of Lausanne
Lausanne
Nicole Sekarski, MD, nicole.sekarski@chuv.ch
Walter Knirsch, MD, walter.knirsch@kispi.uzh.ch
- Recruiting
University Children's Hospital
Zurich, 8032
Walter H Knirsch, MD, +41442667617, walter.knirsch@kispi.uzh.ch
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About this study
Introduction: Congenital heart disease (CHD) is the most frequent birth defect. As survival has significantly improved, attention has turned to neurodevelopmental outcomes of children undergoing heart surgery in early infancy. Since multiple risk factors contribute to neurodevelopmental alterations, a nationwide registry collecting data on medical characteristics, interventions, clinical course and neurodevelopment until school-age is needed to improve the quality of management, identify risk- and protective factors affecting neurodevelopment, and facilitate multicenter trials.
Methods and analysis: The Swiss Outcome Registry for CHIldren with severe congenital heart Disease (ORCHID) is a nationwide, prospective, population-based patient registry developed (1) to collect baseline characteristics and clinical data of CHD patients operated with bypass-surgery or hybrid procedures in the first 6 weeks of life in Switzerland, (2) to monitor long-term neurodevelopment, and (3) to relate clinical characteristics and neurodevelopment to identify risk and protective factors in these children. This registry started data collection relating to pregnancy, birth, preoperative course, catheter-based and surgical treatment, postoperative course and reinterventions in 2019. The primary outcome includes standardised neurodevelopmental assessments at 9 to 12 months, 18 to 24 months and 5.5 to 6 years. Investigators expect to include 80 to 100 children per year. Correlation and regression analyses will be used to investigate risk- and protective factors influencing neurodevelopment.
Ethics and dissemination of results: Swiss ORCHID received support by the Accentus Charitable Foundation, the Anna Mueller Grocholoski Foundation, the Swiss Society of Pediatric Cardiology, and the Corelina - Foundation and was approved by the cantonal ethics committees. Findings will be presented at national and international scientific meetings, and published in peer-reviewed journals. Results will also be shared with patient organizations, primary health care providers, and public health stakeholders to ensure a widespread dissemination of the results.
- Conditions
- Neurodevelopmental Abnormality, Congenital Heart Disease, Cardiac Disease, Intensive Care Neurological Disorder
- Medical subject headings
- Heart Defects, Congenital, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley scales of infant and toddler development III at one year of age
Neurodevelopmental outcome measurement at one year of age (normal value 100, higher values mean better outcome)
Measured: One year of age
Bayley scales of infant and toddler development III at two years of age
Neurodevelopmental outcome measurement at two years of age (normal value 100, higher values mean better outcome)
Measured: Two years of age
Bayley scales of infant and toddler development III at five years of age
Neurodevelopmental outcome measurement at five years of age (normal value 100, higher values mean better outcome)
Measured: Five years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental AbnormalityStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals, University of Geneva, Switzerland, University of Bern
- Responsible party
- Sponsor
- Investigators
- Walter Knirsch, MD, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996211
- Sponsor's protocol ID
- Knirsch 02
- Acronym
- SwissORCHID
- Status last verified
- Aug 2023
- First submitted
- 18 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Natterer J, Schneider J, Sekarski N, Rathke V, Adams M, Latal B, Borradori-Tolsa BT, Bouhabib M, Fuhrer Kradolfer K, Glockler M, Hutter D, Kelly J, L'Ebraly C, Pfluger MR, Polito A, von Rhein M, Knirsch W. ORCHID (Outcome Registry for CHIldren with severe congenital heart Disease) a Swiss, nationwide, prospective, population-based, neurodevelopmental paediatric patient registry: framework, regulations and implementation. Swiss Med Wkly. 2022 Sep 2;152:w30217. doi: 10.4414/smw.2022.w30217. eCollection 2022 Aug 29.
PubMed 36074038Engeli R, Knirsch W, Rathke V, von Rhein M, L'Ebraly C, Grunt S, Kelly-Geyer JF. Perioperative mortality and 1-year neurodevelopmental outcome after cardiac surgery prior to 6 weeks of age, requiring perioperative extracorporeal membrane oxygenation in the first year of life. Front Cardiovasc Med. 2026 Jun 26;13:1828474. doi: 10.3389/fcvm.2026.1828474. eCollection 2026.
PubMed 42434149Knirsch W, De Silvestro A, Rathke V, L'Ebraly C, Natterer JC, Schneider J, Sekarski N, Latal B, Borradori-Tolsa C, Bouhabib MS, Fuhrer Kradolfer K, Glockler M, Hutter D, Pfluger MR, Kaiser L, Polito A, Kelly-Geyer JF, von Rhein M; Swiss ORCHID group. Impact of postoperative necrotizing enterocolitis after neonatal cardiac surgery on neurodevelopmental outcome at 1 year of age. Front Pediatr. 2024 Aug 6;12:1380582. doi: 10.3389/fped.2024.1380582. eCollection 2024.
PubMed 39165487
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Swiss Neurodevelopmental Outcome Registry for Children With CHD
- ClinicalTrials.gov ID
- NCT05996211
- Acronym / sponsor ID
- SwissORCHID / Knirsch 02
- Conditions
- Neurodevelopmental Abnormality, Congenital Heart Disease, Cardiac Disease, Intensive Care Neurological Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals, University of Geneva, Switzerland, University of Bern
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 18 Aug 2023 (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.
Introduction: Congenital heart disease (CHD) is the most frequent birth defect. As survival has significantly improved, attention has turned to neurodevelopmental outcomes of children undergoing heart surgery in early infancy. Since multiple risk factors contribute to neurodevelopmental alterations, a nationwide registry collecting data on medical characteristics, interventions, clinical course and neurodevelopment until school-age is needed to improve the quality of management, identify risk- and protective factors affecting neurodevelopment, and facilitate multicenter trials.
Methods and analysis: The Swiss Outcome Registry for CHIldren with severe congenital heart Disease (ORCHID) is a nationwide, prospective, population-based patient registry developed (1) to collect baseline characteristics and clinical data of CHD patients operated with bypass-surgery or hybrid procedures in the first 6 weeks of life in Switzerland, (2) to monitor long-term neurodevelopment, and (3) to relate clinical characteristics and neurodevelopment to identify risk and protective factors in these children. This registry started data collection relating to pregnancy, birth, preoperative course, catheter-based and surgical treatment, postoperative course and reinterventions in 2019. The primary outcome includes standardised neurodevelopmental assessments at 9 to 12 months, 18 to 24 months and 5.5 to 6 years. Investigators expect to include 80 to 100 children per year. Correlation and regression analyses will be used to investigate risk- and protective factors influencing neurodevelopment.
Ethics and dissemination of results: Swiss ORCHID received support by the Accentus Charitable Foundation, the Anna Mueller Grocholoski Foundation, the Swiss Society of Pediatric Cardiology, and the Corelina - Foundation and was approved by the cantonal ethics committees. Findings will be presented at national and international scientific meetings, and published in peer-reviewed journals. Results will also be shared with patient organizations, primary health care providers, and public health stakeholders to ensure a widespread dissemination of the results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 1 week to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with severe CHD
Key inclusion criteria (2 listed)
- Neonates (including preterm born children) with severe CHD
- Requiring an invasive cardiac intervention (including heart-lung-machine) within the first 6 weeks of life.
Key exclusion criteria (2 listed)
- Neonates (including preterm born children) with simple CHD
- Requiring simple cardiac surgery or catheter intervention such as closure of patent arterial duct or simple repair of aortic coarctation without heart-lung-machine and low impact on neurodevelopmental outcome.
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
Bayley scales of infant and toddler development III at one year of age
Time frame: One year of age
Neurodevelopmental outcome measurement at one year of age (normal value 100, higher values mean better outcome)
Bayley scales of infant and toddler development III at two years of age
Time frame: Two years of age
Neurodevelopmental outcome measurement at two years of age (normal value 100, higher values mean better outcome)
Bayley scales of infant and toddler development III at five years of age
Time frame: Five years of age
Neurodevelopmental outcome measurement at five years of age (normal value 100, higher values mean better outcome)
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 18 Aug 2023.
- Results publication: PubMed 36074038Natterer J, Schneider J, Sekarski N, Rathke V, Adams M, Latal B, Borradori-Tolsa BT, Bouhabib M, Fuhrer Kradolfer K, Glockler M, Hutter D, Kelly J, L'Ebraly C, Pfluger MR, Polito A, von Rhein M, Knirsch W. ORCHID (Outcome Registry for CHIldren with severe congenital heart Disease) a Swiss, nationwide, prospective, population-based, neurodevelopmental paediatric patient registry: framework, regulations and implementation. Swiss Med Wkly. 2022 Sep 2;152:w30217. doi: 10.4414/smw.2022.w30217. eCollection 2022 Aug 29.
- Derived from this study: PubMed 42434149Engeli R, Knirsch W, Rathke V, von Rhein M, L'Ebraly C, Grunt S, Kelly-Geyer JF. Perioperative mortality and 1-year neurodevelopmental outcome after cardiac surgery prior to 6 weeks of age, requiring perioperative extracorporeal membrane oxygenation in the first year of life. Front Cardiovasc Med. 2026 Jun 26;13:1828474. doi: 10.3389/fcvm.2026.1828474. eCollection 2026.
- Derived from this study: PubMed 39165487Knirsch W, De Silvestro A, Rathke V, L'Ebraly C, Natterer JC, Schneider J, Sekarski N, Latal B, Borradori-Tolsa C, Bouhabib MS, Fuhrer Kradolfer K, Glockler M, Hutter D, Pfluger MR, Kaiser L, Polito A, Kelly-Geyer JF, von Rhein M; Swiss ORCHID group. Impact of postoperative necrotizing enterocolitis after neonatal cardiac surgery on neurodevelopmental outcome at 1 year of age. Front Pediatr. 2024 Aug 6;12:1380582. doi: 10.3389/fped.2024.1380582. eCollection 2024.
- Publication of Swiss ORCHIDLink 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.
Walter Knirsch, MD principal investigator
University Children's Hospital, Zurich
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Abnormality and Congenital Heart Disease, run by University Children's Hospital, Zurich at 3 sites 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 2 inclusion and 2 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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Walter Knirsch, MD (+41 44 266 7111, walter.knirsch@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley scales of infant and toddler development III at one year of age (time frame: One year of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05996211, which also lists 3 linked publications.
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 18 Aug 2023.