Contact information
Type
Scientific
Primary contact
Ms Lara Leijser
ORCID ID
Contact details
Leiden University Medical Center (LUMC)
Willem-Alexander Kinder- en Jeugdcentrum
Postzone J6-S
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5262909
L.M.Leijser@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The principal aim of this research project is to establish the origin of increased echogenicity in the thalamus and basal ganglia (TBG), an ultrasonographic finding frequently encountered in very preterm infants. It is not known whether echodensities (ED) of TBG is a normal maturational phenomenon or a pathological process with consequences for neurological development. ED/TBG may, like transient ED in the frontal white matter, represent normal maturational changes occurring in the thalamus, basal ganglia, and/or the surrounding brain tissue. However, it may also represent damage to the developing brain, like more inhomogeneous ED in TBG in (near) term infants, unilateral or localized ED in TBG in preterm infants, linear and/or punctate ED in TBG in preterm and full term infants, and long-lasting ED in the periventricular white matter in preterm infants do. If so, ED/TBG is an important finding and may be associated with an unfavourable or even poor neurological prognosis. We want to explore whether ED/TBG is a pathological phenomenon or a normal (maturational) phenomenon occurring in the immature brain, and to establish the possible consequences of ED/TBG for short and long term neurological outcome of very preterm infants.
Ethics approval
Not provided at time of registration
Study design
Non-randomized, single centre, parallel group study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Preterm infants with hyperechogenicity of TBG
Intervention
In all very preterm infants born after a gestational age of less than 32 weeks, serial cerebral ultrasonography (CUS) examinations will be performed according to the standard protocol. All CUS examinations will be evaluated for the presence of diffuse ED/TBG. This will result in a division of all preterm infants into two groups, i.e. a group of preterm infants with ED/TBG and a group of preterm infants without ED/TBG. All infants (infants with and without ED/TBG) will undergo a single cerebral magnetic resonance imaging (MRI) examination around term date. In addition, they will visit our follow-up clinic around term date and at corrected ages of 12 and 24 months, when their neurodevelopment will be assessed. The results obtained from CUS, MRI and follow-up will be compared between the infants with ED/TBG and the infants without ED/TBG.
The only difference between the two groups of infants is that in one group ED/TBG is detected on CUS, whereas in the other group ED/TBG is not detected. There is no difference between groups in the number of examinations.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The origin and clinical significance of ED/TBG in very preterm infants
Secondary outcome measures
Improvement in the prediction of neurological prognosis of individual preterm infants and the understanding of maturational and pathological processes in the preterm brain
Overall trial start date
03/04/2006
Overall trial end date
31/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Infants born after a gestational age of less than 32 weeks in the Leiden University Medical Center between May 2006 - August 2007.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
140
Participant exclusion criteria
Congenital anomalies or serious acquired abnormalities of the central nervous system, chromosomal disorders, metabolic disorders, neonatal meningitis or sepsis.
Recruitment start date
03/04/2006
Recruitment end date
31/03/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
Funders
Funder type
University/education
Funder name
Leiden University Medical Center (LUMC)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
ZonMw (The Netherlands Organization for Health Research and Development)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list