To prove that 1 corticosteroids administration is the main factor in diminished bone density of preterm neonates, 2 dexamethasone has more influence than hydrocortisone and 3 children with abberant ricketsscreening have a transient diminished boneā¦
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome of the study is a significant diminished SOS in children who
have used corticosteroids as to children who don't have used corticosteroids.
Secondary outcome
Secundary outcome of the study is a wider influence of dexamethasone on bone
density as hydrocortisone.
Background summary
Corticosteroids are frequently used in NICU's to extubate ventilated children
who are difficult to wean. Dexamethasone has different (long term) effects on
bloodpressure, glucose metabolism, growth and braindevelopment. It also seems
to have an effect on bone formation. A previous study invatigating the
influence of antenatal corticoids on calcium metabolism and the correlation
between biochemical parameters in blood and urine and bone density, as measured
bij speed of sound (SOS), showed a temporary diminished bone density in preterm
infants. Hydrocortisone might have less side effects than dexamethasone.
There are other factors (intrauterine growth retardation, chronic lung disease
and long term hospitalization) that may influence bone development. Comparison
of preterm neonates with and without the use of corticoids, with abberant
ricketsscreening and healthy preterm neonates would give more insight in the
cause of temporary diminished bone density.
Study objective
To prove that 1 corticosteroids administration is the main factor in diminished
bone density of preterm neonates, 2 dexamethasone has more influence than
hydrocortisone and 3 children with abberant ricketsscreening have a transient
diminished bone density as compared to the normal premature population.
Study design
Prospective cohort study
Study burden and risks
SOS measurements by Sunlight Omnisense bone sonometer, is a non-invasive
methode without radiation. An ultrasound wave is transmitted axial through the
bone and read by a probe. The attenuation (in dB/MHz) and the speed (SOS, in
m/s) is measured.
Measurements of SOS at the midpoint between the apex of the medial maleolus and
the distal patellar apex as a measure for bone density at the day af birth and
after 1, 3, 6 and 9 weeks. If corticosteroids are used measurements before the
first and after the last gift will be performed as well.
Dr. van Heesweg 2
8025 AB Zwolle
Nederland
Dr. van Heesweg 2
8025 AB Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
Infants born with a gestational age of 26-34 weeks.
Exclusion criteria
Multiple congenital anomalies.
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 | NL17000.075.07 |