The primary objective of this study is to optimize the ultrafast ultrasound flow imaging technique for intra and extra cardiac flow visualization in neonates. The secondary objectives are 1) to compare cardiac output determined using conventional…
ID
Source
Brief title
Condition
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the 2D cardiac and transductal blood flow in
neonates, visualized by ultrafast ultrasound imaging. The ultrafast data
acquisition and flow estimation techniques will be iteratively optimized.
Secondary outcome
Secondary parameters which will be derived from the measurements include
cardiac output, maximum velocity through the ductus arteriosus, changes in
velocity during heart cycle, vorticity and vector concentration of the velocity
field.
Background summary
There is much controversy about optimal management of patent ductus arteriosus
(PDA)
in preterm infants, with the risk of over- and undertreatment. It is
hypothesized that with the use of ultrafast ultrasound blood flow imaging it is
possible to objectively and accurately quantify 2D flow patterns through this
fetal channel. This new technique will provide quantitative measures, which
will potentially enable us to generate new parameters to predict spontaneous
closure of the PDA.
Study objective
The primary objective of this study is to optimize the ultrafast ultrasound
flow imaging technique for intra and extra cardiac flow visualization in
neonates. The secondary objectives are 1) to compare cardiac output determined
using conventional Doppler ultrasound versus ultrafast ultrasound imaging and
2) to gain an insight in the 2D flow patterns involved during closure of the
PDA.
Study design
This study is a prospective, non-randomized, observational, single-center
study. In the study both conventional Doppler ultrasound images and ultrafast
ultrasound images will be obtained and compared.
Study burden and risks
For 3 days, once a day two additional ultrasound examinations will be
performed: a conventional Doppler ultrasound and an ultrafast ultrasound. The
examinations take about 5 minutes each, but will be spread over a time period
of about half an hour because of the time it takes to save the ultrafast
images. This observational exam is associated with negligible risk according to
the risk analysis. Because the study focuses on hemodynamics associated with
PDA it is not possible to perform this study in any other patient group than
neonates.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Newborn infant admitted to the department of Neonatology
Gestational age of 37 weeks or higher
Informed consent obtained from both parents/guardians
Exclusion criteria
Structural heart defects
Life-threatening congenital defects
Condition which severely affects the skin
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL65060.091.18 |