To establish normal ranges for the lateral ventricles in neonates with a gestational age ranging from 25 to 42 weeks.
ID
Source
Brief title
Condition
- Increased intracranial pressure and hydrocephalus
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To establish new reference values that accurately reflect normal values of
lateral ventricular size (ventricular index, anterior horn width and
thalamo-occipital distance) in infants of varying gestational ages.
- Compare these curves with the available data.
- Investigate the influence of the way of delivery on ventricular size
following birth.
Secondary outcome
not applicable
Background summary
Normal values of the size of the lateral ventricles (ventricular index,
anterior horn widht, thalamo-occipital distance) have been determined in
preterm infants with a GA of 25 weeks up to 42 weeks. Reference values are
important to diagnose post-haemorrhagic ventricular dilatation (PHVD) and
evaluate the effect of treatment if initiated.
Reference values of the more mature infants (> 34 weeks) are based on small
numbers. Also, we have clinical reasons to believe that these values are not
always appropriate for our population. In addition, we would like to establish
reference values for the lengte of the occipital horn, as no conclusions for
this clinical significant variable can be drawn from the available literature.
To establish reliable reference ranges, we would like to investigate the
influence of the type of delivery on ventricular size. This will be easily
achievable by repeating ventricular measurements in a part of the cohort after
a few days. In preterm baby*s this is part of routine care, so no extra
ultrasounds have to be made in this group.
Study objective
To establish normal ranges for the lateral ventricles in neonates with a
gestational age ranging from 25 to 42 weeks.
Study design
Prospective study involving neonates at birth. Cranial ultrasound scans will be
performed within the first 3 days of life in neonates admitted to our hospital.
If possible, a second cranial ultrasound will be performed after 72 hours
following birth. Measurements of the lateral ventricles will be performed in a
coronal and sagittal plane.
Study burden and risks
Risk and burden: cranial ultrasound is safe, non-invasive and can be performed
at the bedside. In this study one or two 5 minute ultrasound examinations will
be performed. Therefore, the investigators feel there is no risk and minimal
burden associated with participation in this study.
Benefit: none
Group relatedness: PHVD is a problem which occurs in newborns with intracranial
hemorrhage. Diagnosing intracranial ventricular dilation can only be done if
accurate reference values for newborns of varying gestational ages are
available. Therefore, it is necessary to conduct this research in normal
newborns of varying gestational ages without intracranial abnormalities.
Postbus 85090
3508 AB Utrecht
Nederland
Postbus 85090
3508 AB Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- Postnatal age at examination < 72 hours
- gestational age: all newborn infants
Exclusion criteria
- Abnormalities on cerebral ultrasound: all grades of intraventricular hemorrhage (according to classification of de Vries), periventricular leukomalacie (PVL according to classification of de Vries), cerebral infarction, hydrocephalus, hypoxic-ischemic lesions or structural anatomic problems
- Craniospinal malformation
- Chromosomal or syndromal abnormalities
- Unclear/unknown GA
- Other major birth defects
- Absence of informed parental consent
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 | NL12801.041.06 |