To evaluate the course of concentrations of oxidative stress parameters and neuro-biomarkers in cord blood, serum and urine of full-term asphyxiated neonates. Furthermore, to investigate whether these concentrations are correlated to hypoxic…
ID
Source
Brief title
Condition
- Encephalopathies
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measurement of concentrations of oxidative stress parameters (NPBI,
8-isoprostane) and neuro-biomarkers (S100B, NSE and B-FABP) in cord blood,
arterial blood at 0-6, 72, 108 hours and in saliva and urine at 0-6, 8, 12, 16,
20, 24, 36, 48, 72, 96 en 108 hours after birth.
Outcome measurements for hypoxic ischemic brain injury are brain injury on MRI
(day 3-5) or neonatal mortality.
Secondary outcome
Outcome measurements for adverse long-term outcome are neurodevelopmental
abnormalities at 18 months and 5 years of follow-up.
Background summary
Perinatal asphyxia is a relatively common cause of hypoxic ischemic injury of
the full-term neonatal brain in the Netherlands and can lead to perinatal death
or cognitive and neuro-motor impairment in later life. Despite the use of
clinical encephalopathy scores, amplitude-integrated EEG and MRI for the
estimation of severity of brain injury and prognosis, there is still a demand
for an early and objective diagnostic and prognostic parameter. Former research
suggests that several oxidative stress parameters and neuro-biomarkers could
serve as both diagnostic and prognostic tools early after birth in asphyxiated
neonates with hypoxic ischemic encephalopathy (HIE). However, more research is
necessary to evaluate their diagnostic and prognostic values, which could
contribute to better insight into timing of brain injury, improvement of the
selection criteria for treatment and to discovery of a valuable tool for
treatment evaluation after perinatal asphyxia.
Study objective
To evaluate the course of concentrations of oxidative stress parameters and
neuro-biomarkers in cord blood, serum and urine of full-term asphyxiated
neonates. Furthermore, to investigate whether these concentrations are
correlated to hypoxic ischemic brain injury and adverse neurological outcome.
Study design
Two-center prospective cohort study.
Study burden and risks
In this observational study there are no therapeutic consequences and patients
are subjected to standard clinical care and follow-up. Although participants
will not benefit from this study, the goals of this study are clinically
relevant for similar patient populations. In addition, risks associated with
participation are limited, because samples are obtained non-invasively or with
a negligible burden, whearas the amount of withdrawn blood is acceptable for a
full-term neonate. Furthermore, outcome measurements are all part of standard
clinical care and follow-up in asphyxiated neonates and do not provide an extra
burden to participants.
Postbus 85090
3508 AB Utrecht
NL
Postbus 85090
3508 AB Utrecht
NL
Listed location countries
Age
Inclusion criteria
Gestational age of at least 37 weeks and two of the following criteria:
- Signs of fetal distress: late decelerations or decreased variability of fetal heart rate on
cardiotocography, or meconium stained amnion fluid, or fetal scalp blood ph < 7.2
- Apgar score <=5 at one minute or <= 7 at five minutes
- Arterial cord blood or first pH < 7,00
- Need for ventilation > 5 minutes
- Multi-organ failure
Exclusion criteria
- Congenital malformations
- Documented chromosomal abnormalities
- Inherited errors of metabolism
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 | NL29004.041.10 |