Prematurity; ExtremeSQUIBNCT04535375
Sonographic QUantification of Venous Circulation In the Preterm Brain
A study testing Doppler Ultrasound of venous cerebral circulation in people with Prematurity; Extreme and Cerebral Circulatory Failure, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The aim of the study is to develop an accessible, reproducible ultrasound tool for objective clinical measurement of brain circulation in preterm infants in order to identify infants being at risk for preterm brain injury at an early stage. Read more about this study
- Who is it for?
- Ages Up to 3 hours
- Conditions the study is for
- Prematurity; Extreme, Cerebral Circulatory Failure, Intraventricular Hemorrhage
- What is being tested?
- Doppler Ultrasound of venous cerebral circulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2021to 16 May 2024
- Phase
- Interventional
- 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 3 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infant with a gestational age below 32 0/7 weeks
- birth weight between the 3rd and 97th percentile.
- No cerebral Doppler abnormalities on prenatal ultrasound (i.e. brain sparing)
Who cannot join
- Brain vessel anomaly
- Major congenital malformation
- No parental consent
- IVH > grade 2 (Papile classification or structural brain abnormalities on the first ultrasound
- Severe hemodynamic instability in the first 6 hours of life requiring treatment with inotropes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sonographic Quantification of Venous Circulation in the Preterm Brain
The aim of the study is to develop an accessible, reproducible ultrasound tool for objective clinical measurement of brain circulation in preterm infants in order to identify infants being at risk for preterm brain injury at an early stage. In the future, the results of this study might be useful to select those infants for early interventions aimed at preventing brain injury.
In this study we will identify the normative values of the internal cerebral vein velocity in a reference cohort of stable preterm infants. This stable group of preterm infants is defined as all preterm infants with a birth weight appropriate for gestational age, and without major complications (such as a severe intracranial hemorrhage, severe hemodynamical instability, birth asphyxia) or major congenital malformations.
In this group we will identify subgroups based on moments of clinical instability (sepsis, temporary hypotension, NEC, need for invasive respiratory support) or based on outcome parameters (IVH, PVL, developmental outcomes)
Read the detailed description
The aim of the study is to develop an accessible, reproducible ultrasound tool for objective clinical measurement of brain circulation in preterm infants in order to identify infants being at risk for preterm brain injury at an early stage. In the future, the results of this study might be useful to select those infants for early interventions aimed at preventing brain injury.
In this study we will identify the normative values of the internal cerebral vein velocity in a reference cohort of stable preterm infants. This stable group of preterm infants is defined as all preterm infants with a birth weight appropriate for gestational age, and without major complications (such as a severe intracranial hemorrhage, severe hemodynamical instability, birth asphyxia) or major congenital malformations.
In this group we will identify subgroups based on moments of clinical instability (sepsis, temporary hypotension, NEC, need for invasive respiratory support) or based on outcome parameters (IVH, PVL, developmental outcomes)
Serial brain ultrasound examinations are routinely performed as standard of care after preterm birth for timely de-tection of brain hemorrhage in the first week of life and brain injury in the weeks thereafter until term equivalent age. For infants born between 28 0/7 and 31 6/7 weeks, brain ultrasound is performed on admission, once between day 1 and 3, once between day 7 and 10, and then 2-weekly until discharge or transfer. For infants born before 28 0/7 weeks, standard of care consists of brain ultrasound performed on admission, day 1, day 2, day 3, day 7, and then weekly until discharge.
No additional ultrasound examinations, specifically for the purpose of this study, will be performed. Instead, with each routine ultrasound examination, additional images on top of the routine frames will be collected. Those images will document the velocity and flow in the internal cerebral veins bilaterally using the standard Color Doppler tech-nique. Taking these additional images will prolong the time of ultrasound examination only minimally (with a few minutes).
The ultrasound will be performed using a standardized ultrasound protocol according to Ecury-Goossen et al (18) us-ing the Esaote MyLab Twice (Genova, Italy) with a linear (Esaote LA 435 Linear Array Ultrasound Probe, 6.0-18.0 MHz) and convex probe (Esaote CA123 Convex Array Ultrasound Probe, 3.3-9.0 MHz). This is the standard ultra-sound machine for ultrasound investigations at our neonatology ward.
For routine cranial ultrasound, ten images are generally made through the anterior fontanelle: five in the coronal and five in the sagittal plane. In addition to that, color Doppler or power Doppler is commonly performed in one of the pericallosal arteries in order to evaluate the arterial circulation, quantified by calculating a resistency index (RI). Usually routine ultrasound takes up to 10-15 minutes.
After routine scanning, four extra images will be acquired. These are power doppler images, one per insonated ves-sel of interest. The vessels of interest are the internal cerebral vein (left and right separate, if feasible) and one small tributary (the posterior caudate vein) on each side. To derive these images the duration of the US will be prolonged with approximately 3-5 minutes.
Blood flow velocities (maximum velocity and velocity pattern (17)) can be calculated offline in the anonymously ex-ported dicom file of these four images.
In addition to the ultrasound data, the following clinical patient data will be collected during the study:
- Data on systemic perfusion immediately before each ultrasound: arterial blood pressure, mixed cerebral oxygen saturation using near infrared spectroscopy (NIRS), fractional oxygen extraction, limb oxygen satu-ration, heart rate and use of inotropes.
- Demographic data during hospitalization, such as gender, gestational age, birth weight, head circumfer-ence and complications during hospitalization (infection, surgery, etcetera).
- Conditions
- Prematurity; Extreme, Cerebral Circulatory Failure, Intraventricular Hemorrhage, Periventricular Leukomalacia
- Being tested
- Doppler Ultrasound of venous cerebral circulation
- Keywords
- Preterm infant, extremely preterm infant, Cerebral circulation, Venous Flow, Internal Cerebral Vein, Neurodevelopmental outcome, Intraventricular Hemorrhage, Periventricular Leukomalacia
- Medical subject headings
- Premature Birth, Leukomalacia, Periventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler Ultrasound of venous cerebral circulationDiagnostic test
No additional ultrasound examinations, specifically for the purpose of this study, will be performed. Instead, with each routine ultrasound examination, additional images on top of the routine frames will be collected. Those images will document the velocity and flow in the internal cerebral veins bilaterally using the standard Color Doppler tech-nique. Taking these additional images will prolong the time of ultrasound examination only minimally (with a few minutes).
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants < 28 weeks gestational age | Other | For infants born before 28 0/7 weeks, standard of care consists of brain ultrasound performed on admission, day 1, day 2, day 3, day 7, and then weekly until discharge. Receives: Diagnostic Test: Doppler Ultrasound of venous cerebral circulation |
| Preterm infants born between 28 0/7 and 31 6/7 weeks | Other | For infants born between 28 0/7 and 31 6/7 weeks, brain ultrasound is performed on admission, once between day 1 and 3, once between day 7 and 10, and then 2-weekly until discharge or transfer. Receives: Diagnostic Test: Doppler Ultrasound of venous cerebral circulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normative values of internal cerebral vein velocity
Determination of normative values of ICV velocity and their range in the first weeks of life in stable preterm infants. The Doppler measurements will be performed at several moments after birth: day 0, 1, 2, 3, 7, 14, 21, etc untill 36 weeks gestational age.
For this purpose we will calculate the Maximum velocity (cm/s), the mean velocity (cm/s) and the variability (according to Ikeda et al) of the flow pattern in the Internal Cerebral Vein. These velocities will be plotted in an attempt to discover longitudinal normative values in this cohort of 50 preterm infants.
Measured: 2-3 years
Secondary outcomes (2)
Short-term outcome: cerebral complications in the neonatal phase
Relation of ICV flow with IVH grade 2 or more (according to the Papile classification), periventricular leukomalacia, ventriculomegaly, white matter disease, selective neuronal necrosis assessed by routinely performed MRI scan of the brain at term equivalent age.
Measured: 2-3 years
Long-term outcome: neurodevelopmental impairment
Relation of ICV flow with Bayley mental and motor scales at 2 years of age, as rou-tinely performed by the COS - Centrum voor Ontwikkelingsstoornissen.
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Jan 2021
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Prematurity; ExtremeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All stable preterm infants born before a gestational age of 32 weeks are eligible for inclusion. Since standard ultrasound protocol is different for preterm infants born below or after 28 weeks, two subgroups will be created.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fleur Anne Camfferman, Universitair Ziekenhuis Brussel
- Investigators
- Paul Govaert, MD PhD, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535375
- Sponsor's protocol ID
- SQUIB2020
- Acronym
- SQUIB
- Status last verified
- May 2024
- First submitted
- 27 Aug 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For future systematic reviews anonimized individual participant data can be made available is an e-mail request is addressed at the principal investigator.
Publications
Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978 Apr;92(4):529-34. doi: 10.1016/s0022-3476(78)80282-0.
PubMed 305471Osborn DA, Evans N, Kluckow M. Hemodynamic and antecedent risk factors of early and late periventricular/intraventricular hemorrhage in premature infants. Pediatrics. 2003 Jul;112(1 Pt 1):33-9. doi: 10.1542/peds.112.1.33.
PubMed 12837865Kluckow M, Evans N. Low superior vena cava flow and intraventricular haemorrhage in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F188-94. doi: 10.1136/fn.82.3.f188.
PubMed 10794784Caicedo A, Naulaers G, Lemmers P, van Bel F, Wolf M, Van Huffel S. Detection of cerebral autoregulation by near-infrared spectroscopy in neonates: performance analysis of measurement methods. J Biomed Opt. 2012 Nov;17(11):117003. doi: 10.1117/1.JBO.17.11.117003.
PubMed 23117814de Waal KA, Evans N, Osborn DA, Kluckow M. Cardiorespiratory effects of changes in end expiratory pressure in ventilated newborns. Arch Dis Child Fetal Neonatal Ed. 2007 Nov;92(6):F444-8. doi: 10.1136/adc.2006.103929. Epub 2007 Apr 25.
PubMed 17460022Hamon I, Hascoet JM, Debbiche A, Vert P. Effects of fentanyl administration on general and cerebral haemodynamics in sick newborn infants. Acta Paediatr. 1996 Mar;85(3):361-5. doi: 10.1111/j.1651-2227.1996.tb14033.x.
PubMed 8695997Skov L, Hellstrom-Westas L, Jacobsen T, Greisen G, Svenningsen NW. Acute changes in cerebral oxygenation and cerebral blood volume in preterm infants during surfactant treatment. Neuropediatrics. 1992 Jun;23(3):126-30. doi: 10.1055/s-2008-1071327.
PubMed 1641080Caicedo A, De Smet D, Naulaers G, Ameye L, Vanderhaegen J, Lemmers P, Van Bel F, Van Huffel S. Cerebral tissue oxygenation and regional oxygen saturation can be used to study cerebral autoregulation in prematurely born infants. Pediatr Res. 2011 Jun;69(6):548-53. doi: 10.1203/PDR.0b013e3182176d85.
PubMed 21364491van Bel F, Mintzer JP. Monitoring cerebral oxygenation of the immature brain: a neuroprotective strategy? Pediatr Res. 2018 Aug;84(2):159-164. doi: 10.1038/s41390-018-0026-8. Epub 2018 Aug 16.
PubMed 29907853Couture A, Veyrac C, Baud C, Saguintaah M, Ferran JL. Advanced cranial ultrasound: transfontanellar Doppler imaging in neonates. Eur Radiol. 2001;11(12):2399-410. doi: 10.1007/s00330-001-1150-z. Epub 2001 Oct 30.
PubMed 11734933Camfferman FA, de Goederen R, Govaert P, Dudink J, van Bel F, Pellicer A, Cools F; eurUS.brain group. Diagnostic and predictive value of Doppler ultrasound for evaluation of the brain circulation in preterm infants: a systematic review. Pediatr Res. 2020 Mar;87(Suppl 1):50-58. doi: 10.1038/s41390-020-0777-x.
PubMed 32218536Kluckow M, Evans N. Superior vena cava flow in newborn infants: a novel marker of systemic blood flow. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F182-7. doi: 10.1136/fn.82.3.f182.
PubMed 10794783Evans N, Kluckow M, Simmons M, Osborn D. Which to measure, systemic or organ blood flow? Middle cerebral artery and superior vena cava flow in very preterm infants. Arch Dis Child Fetal Neonatal Ed. 2002 Nov;87(3):F181-4. doi: 10.1136/fn.87.3.f181.
PubMed 12390987McGovern M, Miletin J. A review of superior vena cava flow measurement in the neonate by functional echocardiography. Acta Paediatr. 2017 Jan;106(1):22-29. doi: 10.1111/apa.13584. Epub 2016 Sep 28.
PubMed 27611695Lee A, Liestol K, Nestaas E, Brunvand L, Lindemann R, Fugelseth D. Superior vena cava flow: feasibility and reliability of the off-line analyses. Arch Dis Child Fetal Neonatal Ed. 2010 Mar;95(2):F121-5. doi: 10.1136/adc.2009.176883. Epub 2009 Dec 8.
PubMed 19996328
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Quantification of Venous Circulation in the Preterm Brain
- ClinicalTrials.gov ID
- NCT04535375
- Acronym / sponsor ID
- SQUIB / SQUIB2020
- Conditions
- Prematurity; Extreme, Cerebral Circulatory Failure, Intraventricular Hemorrhage, Periventricular Leukomalacia
- Keywords
- Preterm infant, extremely preterm infant, Cerebral circulation, Venous Flow, Internal Cerebral Vein, Neurodevelopmental outcome, Intraventricular Hemorrhage, Periventricular Leukomalacia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 2 Sep 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 aim of the study is to develop an accessible, reproducible ultrasound tool for objective clinical measurement of brain circulation in preterm infants in order to identify infants being at risk for preterm brain injury at an early stage. In the future, the results of this study might be useful to select those infants for early interventions aimed at preventing brain injury.
In this study we will identify the normative values of the internal cerebral vein velocity in a reference cohort of stable preterm infants. This stable group of preterm infants is defined as all preterm infants with a birth weight appropriate for gestational age, and without major complications (such as a severe intracranial hemorrhage, severe hemodynamical instability, birth asphyxia) or major congenital malformations.
In this group we will identify subgroups based on moments of clinical instability (sepsis, temporary hypotension, NEC, need for invasive respiratory support) or based on outcome parameters (IVH, PVL, developmental outcomes)
Detailed description
The aim of the study is to develop an accessible, reproducible ultrasound tool for objective clinical measurement of brain circulation in preterm infants in order to identify infants being at risk for preterm brain injury at an early stage. In the future, the results of this study might be useful to select those infants for early interventions aimed at preventing brain injury.
In this study we will identify the normative values of the internal cerebral vein velocity in a reference cohort of stable preterm infants. This stable group of preterm infants is defined as all preterm infants with a birth weight appropriate for gestational age, and without major complications (such as a severe intracranial hemorrhage, severe hemodynamical instability, birth asphyxia) or major congenital malformations.
In this group we will identify subgroups based on moments of clinical instability (sepsis, temporary hypotension, NEC, need for invasive respiratory support) or based on outcome parameters (IVH, PVL, developmental outcomes)
Serial brain ultrasound examinations are routinely performed as standard of care after preterm birth for timely de-tection of brain hemorrhage in the first week of life and brain injury in the weeks thereafter until term equivalent age. For infants born between 28 0/7 and 31 6/7 weeks, brain ultrasound is performed on admission, once between day 1 and 3, once between day 7 and 10, and then 2-weekly until discharge or transfer. For infants born before 28 0/7 weeks, standard of care consists of brain ultrasound performed on admission, day 1, day 2, day 3, day 7, and then weekly until discharge.
No additional ultrasound examinations, specifically for the purpose of this study, will be performed. Instead, with each routine ultrasound examination, additional images on top of the routine frames will be collected. Those images will document the velocity and flow in the internal cerebral veins bilaterally using the standard Color Doppler tech-nique. Taking these additional images will prolong the time of ultrasound examination only minimally (with a few minutes).
The ultrasound will be performed using a standardized ultrasound protocol according to Ecury-Goossen et al (18) us-ing the Esaote MyLab Twice (Genova, Italy) with a linear (Esaote LA 435 Linear Array Ultrasound Probe, 6.0-18.0 MHz) and convex probe (Esaote CA123 Convex Array Ultrasound Probe, 3.3-9.0 MHz). This is the standard ultra-sound machine for ultrasound investigations at our neonatology ward.
For routine cranial ultrasound, ten images are generally made through the anterior fontanelle: five in the coronal and five in the sagittal plane. In addition to that, color Doppler or power Doppler is commonly performed in one of the pericallosal arteries in order to evaluate the arterial circulation, quantified by calculating a resistency index (RI). Usually routine ultrasound takes up to 10-15 minutes.
After routine scanning, four extra images will be acquired. These are power doppler images, one per insonated ves-sel of interest. The vessels of interest are the internal cerebral vein (left and right separate, if feasible) and one small tributary (the posterior caudate vein) on each side. To derive these images the duration of the US will be prolonged with approximately 3-5 minutes.
Blood flow velocities (maximum velocity and velocity pattern (17)) can be calculated offline in the anonymously ex-ported dicom file of these four images.
In addition to the ultrasound data, the following clinical patient data will be collected during the study:
- Data on systemic perfusion immediately before each ultrasound: arterial blood pressure, mixed cerebral oxygen saturation using near infrared spectroscopy (NIRS), fractional oxygen extraction, limb oxygen satu-ration, heart rate and use of inotropes.
- Demographic data during hospitalization, such as gender, gestational age, birth weight, head circumfer-ence and complications during hospitalization (infection, surgery, etcetera).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All stable preterm infants born before a gestational age of 32 weeks are eligible for inclusion. Since standard ultrasound protocol is different for preterm infants born below or after 28 weeks, two subgroups will be created.
| Arm | Type | Receives |
|---|---|---|
| Preterm infants < 28 weeks gestational age | Other | Diagnostic Test: Doppler Ultrasound of venous cerebral circulationFor infants born before 28 0/7 weeks, standard of care consists of brain ultrasound performed on admission, day 1, day 2, day 3, day 7, and then weekly until discharge. |
| Preterm infants born between 28 0/7 and 31 6/7 weeks | Other | Diagnostic Test: Doppler Ultrasound of venous cerebral circulationFor infants born between 28 0/7 and 31 6/7 weeks, brain ultrasound is performed on admission, once between day 1 and 3, once between day 7 and 10, and then 2-weekly until discharge or transfer. |
Who may qualify
- Ages
- Up to 3 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infant with a gestational age below 32 0/7 weeks
- birth weight between the 3rd and 97th percentile.
- No cerebral Doppler abnormalities on prenatal ultrasound (i.e. brain sparing)
Key exclusion criteria (5 listed)
- Brain vessel anomaly
- Major congenital malformation
- No parental consent
- IVH > grade 2 (Papile classification or structural brain abnormalities on the first ultrasound
- Severe hemodynamic instability in the first 6 hours of life requiring treatment with inotropes.
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 |
|---|---|---|
| Doppler Ultrasound of venous cerebral circulationNo additional ultrasound examinations, specifically for the purpose of this study, will be performed. Instead, with each routine ultrasound examination, additional images on top of the routine frames will be collected. Those images will document the velocity and flow in the internal cerebral veins bilaterally using the standard Color Doppler tech-nique. Taking these additional images will prolong the time of ultrasound examination only minimally (with a few minutes). | Diagnostic test | Preterm infants < 28 weeks gestational age, Preterm infants born between 28 0/7 and 31 6/7 weeks |
Primary outcome
Normative values of internal cerebral vein velocity
Time frame: 2-3 years
Determination of normative values of ICV velocity and their range in the first weeks of life in stable preterm infants. The Doppler measurements will be performed at several moments after birth: day 0, 1, 2, 3, 7, 14, 21, etc untill 36 weeks gestational age. For this purpose we will calculate the Maximum velocity (cm/s), the mean velocity (cm/s) and the variability (according to Ikeda et al) of the flow pattern in the Internal Cerebral Vein. These velocities will be plotted in an attempt to discover longitudinal normative values in this cohort of 50 preterm infants.
2 secondary outcomes
Short-term outcome: cerebral complications in the neonatal phase
Time frame: 2-3 years
Long-term outcome: neurodevelopmental impairment
Time frame: 3-5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Background: PubMed 305471Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978 Apr;92(4):529-34. doi: 10.1016/s0022-3476(78)80282-0.
- Background: PubMed 12837865Osborn DA, Evans N, Kluckow M. Hemodynamic and antecedent risk factors of early and late periventricular/intraventricular hemorrhage in premature infants. Pediatrics. 2003 Jul;112(1 Pt 1):33-9. doi: 10.1542/peds.112.1.33.
- Background: PubMed 10794784Kluckow M, Evans N. Low superior vena cava flow and intraventricular haemorrhage in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F188-94. doi: 10.1136/fn.82.3.f188.
- Background: PubMed 23117814Caicedo A, Naulaers G, Lemmers P, van Bel F, Wolf M, Van Huffel S. Detection of cerebral autoregulation by near-infrared spectroscopy in neonates: performance analysis of measurement methods. J Biomed Opt. 2012 Nov;17(11):117003. doi: 10.1117/1.JBO.17.11.117003.
- Background: PubMed 17460022de Waal KA, Evans N, Osborn DA, Kluckow M. Cardiorespiratory effects of changes in end expiratory pressure in ventilated newborns. Arch Dis Child Fetal Neonatal Ed. 2007 Nov;92(6):F444-8. doi: 10.1136/adc.2006.103929. Epub 2007 Apr 25.
- Background: PubMed 8695997Hamon I, Hascoet JM, Debbiche A, Vert P. Effects of fentanyl administration on general and cerebral haemodynamics in sick newborn infants. Acta Paediatr. 1996 Mar;85(3):361-5. doi: 10.1111/j.1651-2227.1996.tb14033.x.
- Background: PubMed 1641080Skov L, Hellstrom-Westas L, Jacobsen T, Greisen G, Svenningsen NW. Acute changes in cerebral oxygenation and cerebral blood volume in preterm infants during surfactant treatment. Neuropediatrics. 1992 Jun;23(3):126-30. doi: 10.1055/s-2008-1071327.
- Background: PubMed 21364491Caicedo A, De Smet D, Naulaers G, Ameye L, Vanderhaegen J, Lemmers P, Van Bel F, Van Huffel S. Cerebral tissue oxygenation and regional oxygen saturation can be used to study cerebral autoregulation in prematurely born infants. Pediatr Res. 2011 Jun;69(6):548-53. doi: 10.1203/PDR.0b013e3182176d85.
- Background: PubMed 29907853van Bel F, Mintzer JP. Monitoring cerebral oxygenation of the immature brain: a neuroprotective strategy? Pediatr Res. 2018 Aug;84(2):159-164. doi: 10.1038/s41390-018-0026-8. Epub 2018 Aug 16.
- Background: PubMed 11734933Couture A, Veyrac C, Baud C, Saguintaah M, Ferran JL. Advanced cranial ultrasound: transfontanellar Doppler imaging in neonates. Eur Radiol. 2001;11(12):2399-410. doi: 10.1007/s00330-001-1150-z. Epub 2001 Oct 30.
- Background: PubMed 32218536Camfferman FA, de Goederen R, Govaert P, Dudink J, van Bel F, Pellicer A, Cools F; eurUS.brain group. Diagnostic and predictive value of Doppler ultrasound for evaluation of the brain circulation in preterm infants: a systematic review. Pediatr Res. 2020 Mar;87(Suppl 1):50-58. doi: 10.1038/s41390-020-0777-x.
- Background: PubMed 10794783Kluckow M, Evans N. Superior vena cava flow in newborn infants: a novel marker of systemic blood flow. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F182-7. doi: 10.1136/fn.82.3.f182.
- Individual participant dataSharing planned: No. For future systematic reviews anonimized individual participant data can be made available is an e-mail request is addressed at the principal investigator.
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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. This study is not recruiting at the moment.
Paul Govaert, MD PhD study chair
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler Ultrasound of venous cerebral circulation in people with Prematurity; Extreme and Cerebral Circulatory Failure, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 5 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: finished, as of the sponsor's last update on 17 May 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normative values of internal cerebral vein velocity (time frame: 2-3 years). 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 NCT04535375, which also lists 21 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 17 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.