Condition category
Nervous System Diseases
Date applied
29/06/2006
Date assigned
29/06/2006
Last edited
10/07/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Leiden University Medical Center (LUMC) (The Netherlands)

Sponsor details

P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

University/education

Website

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes