The primary objective in this observational study is to determine microcirculatory profile in preterm and term neonates. We would like to determine how the microcirculation changes in time during the phase of adaptation and correlate inter- and…
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Brief title
Condition
- Red blood cell disorders
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective in this observational study is to determine
microcirculatory profile in preterm and term neonates. We would like to
determine how the microcirculation changes in time during the phase of
adaptation and correlate inter- and intra-patient variations with clinical
signs of maladaptation.
The microcirculation profile consists of:
• Microcirculatory perfusion defined by the parameters PVD and MFI
• RBC deformability defined by Elongation Index
• Cerebral tissue oxygenation defined as cerebral saturation (rScO2), and
cerebral fractional tissue oxygen extraction (cFTOE)
• NO metabolism measured by urine nitrite and nitrate concentration
• Formation of ROS measured by urine malondialdehyde
In this study we will examine:
• The relationship between the microcirculation and routinely obtained
macrocirculatory parameters
• The relationship between microcirculatory perfusion (defined by the
parameters PVD & MFI) and RBC rheology (defined by the parameters RBC
deformability)
• The relationship between microcirculatory perfusion (defined by the
parameters PVD & MFI) and NO metabolism (defined by the parameters urine
nitrite and nitrate)
• The effect of oxygen administration on NO-signaling pathways and ROS formation
• To evaluate if routine treatment options as surfactant administration and red
blood cell transfusion improves the microcirculation
Secondary outcome
nvt
Background summary
The microcirculation is an important, but under-evaluated part in neonatal
physiology. Maladaptation in the phase before and after birth has short and
long-term consequences. Excessive oxygen administration and thus the formation
of reactive oxygen species leads to interferences of the NO pathway and
destructive effects on DNA. Neonatal maladaptation is associated with increased
risk of cardiovascular disease in adult life.
The ability of the fetus to withstand profound and sustained hypoxia in utero
may serve as a model from which to develop strategies to improve survival in
hypoxemic critically ill patients. With a better understanding of the
relationship between hypoxemia and tissue hypoxia, *permissive hypoxemia* could
become a realistic possibility in selected patient cohorts. Simply adding more
oxygen at the top of the oxygen cascade may not be the solution to
disequilibrium at a tissue level.
Recent technological developments enable us to acquire more detailed
information about tissue oxygenation and factors that contribute to the
microcirculation. Through the establishment of microcirculatory profiles,
knowledge will be acquired for further investigation of predictive value of non
invasive functional biomarkers. Ultimately, this may lead to the identification
of high risk patients and improved treatment strategies of tissue oxygenation
and thereby improved outcome of neonates.
Study objective
The primary objective in this observational study is to determine
microcirculatory profile in preterm and term neonates. We would like to
determine how the microcirculation changes in time during the phase of
adaptation and correlate inter- and intra-patient variations with clinical
signs of maladaptation
Study design
Observational study conducted at the Neonatology Intensive Care Unit (NICU) and
maternity ward (healthy control group) of the Erasmus MC - Sophia.
Study burden and risks
Due to the observational character of this study, the risks are very small. We
aim to assess the objectives mainly using non-invasive techniques. No adverse
events have been reported using Cytocam and NIRS. The only possible burden
could be that some minor manipulation of the infant may be required to obtain
qualitatively good images. Urine samples will be obtained in a non-invasive
manner using gauze in the diaper. Blood samples will only be obtained when the
infant is already punctured for medical reasons or when an arterial catheter is
in place. Because of the low frequency and quantity for determination (3 times
0.1 ml), risk for anemia is small.
Dr. Molewaterplein 60
Rotterdam 3015GJ
NL
Dr. Molewaterplein 60
Rotterdam 3015GJ
NL
Listed location countries
Age
Inclusion criteria
- Neonates born with a gestational age between 24 weeks and 32 weeks and admission to the(NICU)
- Neonates born with a gestational age after 37 weeks suffering from asphyxia and admitted to the NICU
- Neonates born with a gestational age after 37 weeks and admitted to the maternity ward
- Written informed consent obtained from parent(s) of caregiver(s)
- Age < 24hours
Exclusion criteria
- Age >= 24hours
- Patients with (the suspicion of) hematologic disorders
- Patients with (the suspicion of) lethal congenital malformations
- Absence of written informed 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 | NL40946.078.12 |