Hypoperfusion in Newborn With Congenital Heart DiseaseFLOWERNCT04713605
Cerebral Blood Flow in Neonates During Major Cardiac Surgery.
An observational study of Hypoperfusion in Newborn With Congenital Heart Disease, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Rationale: During cardiac surgery, neonates are at high risk of cerebral damage: 36-78% will have new cerebral lesions after surgery. Adequate cerebral perfusion (CBF) is mandatory to prevent postoperative brain damage and neurobehavioral outcomes. Read more about this study
- Who is it for?
- Ages Up to 6 weeks
- Conditions the study is for
- Hypoperfusion in Newborn With Congenital Heart Disease
- What is being tested?
- Critical closing pressure detection
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Mar 2022to Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 6 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Eligible patients are term infants within 42 days (6 weeks) after birth, or infants prematurely born (with a gestational age >32 weeks) at a corrected age of <42 days, who are scheduled for cardiac or non-cardiac surgery.
Who may be able to join
- Term infant aged < 42 days / Preterm born > 32 weeks and with a corrected age < 42 days
- (Semi-) elective cardiac of major non-cardiac surgery
- Routine placement of an arterial cannula for invasive blood pressure monitoring.
Who cannot join
- Grade III-IV intracranial hemorrhage.
- Emergency surgery or semi-elective surgery performed out of hours.
- Informed consent from the parents is not obtained.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht / Wilhelmina Children's Hospital
Utrecht, 3508GA
K van Loon, MD, PhD, +31 88 75 59475, K.vanLoon-2@umcutrecht.nl
I Ceelie, MD, PhD, +31 88 75 59475, I.Ceelie-2@umcutrecht.nl
About this study
Official title: Cerebral Blood Flow in Neonates During Major Cardiac- and Non-cardiac Surgery
Rationale: During cardiac surgery, neonates are at high risk of cerebral damage: 36-78% will have new cerebral lesions after surgery. Adequate cerebral perfusion (CBF) is mandatory to prevent postoperative brain damage and neurobehavioral outcomes. For CBF, the systemic blood pressure should be managed above the brain's critical closing pressure (CrCP), and preferably above the lower limit of autoregulation (LLA), if intact.
Objective: The investigators aim to study the patient specific threshold for arterial blood pressure to maintain adequate cerebral perfusion (CBFV) in the perioperative setting and the association between perioperative abnormalities with postoperative brain damage and neurobehavioral outcomes.
Read more
Study design: In a prospective observational cohort study bilateral cerebral blood flow velocity (CBFV) measurements are performed with transcranial doppler (TCD), together with invasive arterial blood pressure (iABP) measurements in the perioperative period.
Study population: Neonates (semi-) electively scheduled for major cardiac- and non cardiac surgery.
Main study parameters/endpoints: Main study endpoint is the Critical Closing Pressure (CrCP) within and between subjects. Furthermore, we evaluate the association with new white matter injury (WMI) on the postoperative MRI.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Anticipated risks caused by TCD monitoring in neonates are considered negligible when monitoring is executed according to the BMUS guidelines and ALARA principle. Each time energy is converted from one form to another, part of it is inevitably converted to heat. Theoretically, if at all, the maximum temperature rise will happen at the skin- temporal bone side, where the monitoring probes are placed. A maximal thermal index (TI) of 0.7 is allowed, this corresponds with 0.7 o C temperature rise.
Patients might not benefit from participation in this study as the TCD measurements are only visible and available to the TCD operator, and we do not yet know how the results could possibly influence the procedure. However, in the unlikely situation where cerebral perfusion is severely compromised for a longer period of time or in case of occurrence of large air emboli, improper cannulation or cross clamping the cardiac team will be notified. Therefore, a neonate might benefit from participation.
- Being tested
- Critical closing pressure detection
- Keywords
- TCD, hypoperfusion, critical closing pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical closing pressure detectionDevice
Observational study that determines the critical closing pressure (CrCP) of the brain by comparison of the cerebral blood flow velocity (measured by TCD) and invasive blood pressure measurement (IABP)
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical Closing Pressure (CrCP)
Detection of the critical closing pressure (CrCP) of the brain, the arterial blood pressure at which brain vessels collapse and cerebral blood flow ceases, in a cohort of neonates who need major cardiac surgery. We hypothesize that neonates have a unique CrCP and cerebral ischemia occurs during episodes with critically endangered blood supply to the brain, when the arterial blood pressure (iABP) is below CrCP.
Measured: During congenital heart surgery
Secondary outcomes (1)
Incidence white matter injury (WMI) on the postoperative MRI.
Compare CrCP between outcome groups, absent or new white matter injury (WMI) on the postoperative MRI.
Measured: Within the first postoperative 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start23 Mar 2022
- Primary completionJul 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoperfusion in Newborn With Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim van Loon, UMC Utrecht
- Investigators
- Kim van Loon, MD, PhD, Principal investigator, University Medical Center Utrecht / Wilhelmina Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713605
- Sponsor's protocol ID
- NL76532.041.21
- Acronym
- FLOWER
- Status last verified
- Mar 2024
- First submitted
- 13 Jan 2021
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Martherus BV, Alderliesten T, Fonteyn EMR, Ceelie I, van Vriesland DJ, Nijman J, Talacua H, Nievelstein RAJ, Dudink J, Benders MJNL, Buhre WFFA, van Loon K. Bilateral Transcranial Doppler Monitoring During Neonatal Cardiac Surgery; Guidance for Clinical and Scientific Use. Paediatr Anaesth. 2026 Apr;36(4):370-378. doi: 10.1002/pan.70106. Epub 2025 Dec 24.
PubMed 41439495
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Blood Flow in Neonates During Major Cardiac- and Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT04713605
- Acronym / sponsor ID
- FLOWER / NL76532.041.21
- Keywords
- TCD, hypoperfusion, critical closing pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 19 Jan 2021 (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.
Rationale: During cardiac surgery, neonates are at high risk of cerebral damage: 36-78% will have new cerebral lesions after surgery. Adequate cerebral perfusion (CBF) is mandatory to prevent postoperative brain damage and neurobehavioral outcomes. For CBF, the systemic blood pressure should be managed above the brain's critical closing pressure (CrCP), and preferably above the lower limit of autoregulation (LLA), if intact.
Objective: The investigators aim to study the patient specific threshold for arterial blood pressure to maintain adequate cerebral perfusion (CBFV) in the perioperative setting and the association between perioperative abnormalities with postoperative brain damage and neurobehavioral outcomes.
Study design: In a prospective observational cohort study bilateral cerebral blood flow velocity (CBFV) measurements are performed with transcranial doppler (TCD), together with invasive arterial blood pressure (iABP) measurements in the perioperative period.
Study population: Neonates (semi-) electively scheduled for major cardiac- and non cardiac surgery.
Main study parameters/endpoints: Main study endpoint is the Critical Closing Pressure (CrCP) within and between subjects. Furthermore, we evaluate the association with new white matter injury (WMI) on the postoperative MRI.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Anticipated risks caused by TCD monitoring in neonates are considered negligible when monitoring is executed according to the BMUS guidelines and ALARA principle. Each time energy is converted from one form to another, part of it is inevitably converted to heat. Theoretically, if at all, the maximum temperature rise will happen at the skin- temporal bone side, where the monitoring probes are placed. A maximal thermal index (TI) of 0.7 is allowed, this corresponds with 0.7 o C temperature rise.
Patients might not benefit from participation in this study as the TCD measurements are only visible and available to the TCD operator, and we do not yet know how the results could possibly influence the procedure. However, in the unlikely situation where cerebral perfusion is severely compromised for a longer period of time or in case of occurrence of large air emboli, improper cannulation or cross clamping the cardiac team will be notified. Therefore, a neonate might benefit from participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Eligible patients are term infants within 42 days (6 weeks) after birth, or infants prematurely born (with a gestational age >32 weeks) at a corrected age of <42 days, who are scheduled for cardiac or non-cardiac surgery.
Key inclusion criteria (3 listed)
- Term infant aged < 42 days / Preterm born > 32 weeks and with a corrected age < 42 days
- (Semi-) elective cardiac of major non-cardiac surgery
- Routine placement of an arterial cannula for invasive blood pressure monitoring.
Key exclusion criteria (3 listed)
- Grade III-IV intracranial hemorrhage.
- Emergency surgery or semi-elective surgery performed out of hours.
- Informed consent from the parents is not obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical closing pressure detectionObservational study that determines the critical closing pressure (CrCP) of the brain by comparison of the cerebral blood flow velocity (measured by TCD) and invasive blood pressure measurement (IABP) | Device | – |
Primary outcome
Critical Closing Pressure (CrCP)
Time frame: During congenital heart surgery
Detection of the critical closing pressure (CrCP) of the brain, the arterial blood pressure at which brain vessels collapse and cerebral blood flow ceases, in a cohort of neonates who need major cardiac surgery. We hypothesize that neonates have a unique CrCP and cerebral ischemia occurs during episodes with critically endangered blood supply to the brain, when the arterial blood pressure (iABP) is below CrCP.
1 secondary outcome
Incidence white matter injury (WMI) on the postoperative MRI.
Time frame: Within the first postoperative 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Derived from this study: PubMed 41439495Martherus BV, Alderliesten T, Fonteyn EMR, Ceelie I, van Vriesland DJ, Nijman J, Talacua H, Nievelstein RAJ, Dudink J, Benders MJNL, Buhre WFFA, van Loon K. Bilateral Transcranial Doppler Monitoring During Neonatal Cardiac Surgery; Guidance for Clinical and Scientific Use. Paediatr Anaesth. 2026 Apr;36(4):370-378. doi: 10.1002/pan.70106. Epub 2025 Dec 24.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
Kim van Loon, MD, PhD principal investigator
University Medical Center Utrecht / Wilhelmina Children's Hospital
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 Hypoperfusion in Newborn With Congenital Heart Disease, run by UMC Utrecht at 1 site in Netherlands.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Mar 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvia van Rossum (+31887561101, S.M.vanRossum-5@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Critical Closing Pressure (CrCP) (time frame: During congenital heart surgery). 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 NCT04713605, which also lists 1 linked publication.
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 27 Mar 2024.