Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04535375
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2020-08-27
Brief Title:
Sonographic QUantification of Venous Circulation In the Preterm Brain
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
Sonographic Quantification of Venous Circulation in the Preterm Brain
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SQUIB
Brief 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 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
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 07 and 31 67 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 07 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 60-180 MHz and convex probe Esaote CA123 Convex Array Ultrasound Probe 33-90 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
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 07 and 31 67 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 07 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 60-180 MHz and convex probe Esaote CA123 Convex Array Ultrasound Probe 33-90 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None