No registrations found.
ID
Source
Brief title
Health condition
Adaptation
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 interand
intra-patient variations with clinical signs of maladaptation. Hereby we like to
determine what a normal and what an abnormal microcirculatory profile is.
Secondary outcome
1. The relationship between the microcirculation and routinely obtained
macrocirculatory parameters;
2. The relationship between microcirculatory perfusion (defined by the
parameters PVD & MFI) and RBC deformability;
3. The relationship between microcirculatory perfusion (defined by the
parameters PVD & MFI) and NO metabolism (defined by the parameters urine
nitrite and nitrate);
4. The effect of oxygen administration on NO-signaling pathways and ROS
formation;
5. To evaluate if routine treatment options as surfactant administration and red
blood cell transfusion improves the microcirculation.
Background summary
Adaptation after birth is a process which occurs in every newborn. Maladaptation leads to hypoxia and potential toxic oxygen administration. The microcirculation might play an important role in the pathogenesis of maladaptation and may have significant effects on later life. We would like to establish microcirculatory profiles focussed on the first week of life. Hereby we like to determine what a normal and what an abnormal microcirculatory profile is.
Study objective
The microcirculation can be a supportive non-invasive biomarker for making clinical decisions and even help to predict sepsis and mortality in the Neonatal Intensive Care Unit.
Study design
CytoCam and NIRS data will be obtained within the first 24 hours after birth (T1).
Thereafter, measurements will be done on day 3 (T2), 5 (T3) and 7 (T4). If the patient
is still admitted to the NICU, measurements will be repeated at day 14 (T5) and day
28 (T6) to complete the neonatal period.
Red blood cell deformability and urine nitrite/nitrate/malondialdehyde will be measured at T1, T2 and T4.
Intervention
This is an observational study. The following techniques will be used to determine microcirculatory profiles:
1. Sidestream Darkfield Imaging and CytoCam;
2. NIRS;
3. Red blood cell deformability using LORCA;
4. Urine samples measuring nitrate/nitrite and malondialdehyde.
Department of Pediatrics<br>
Room SK-2210<br>
Dr. Molewaterplein 60<br>
Postbus 2060
H.A. Elteren, van
Rotterdam 3000 CB
The Netherlands
+31 (0)10 7036015
h.vanelteren@erasmusmc.nl
Department of Pediatrics<br>
Room SK-2210<br>
Dr. Molewaterplein 60<br>
Postbus 2060
H.A. Elteren, van
Rotterdam 3000 CB
The Netherlands
+31 (0)10 7036015
h.vanelteren@erasmusmc.nl
Inclusion criteria
1. Neonates born with a gestational age between 24 weeks and 43 weeks;
2. Admission to the NICU or maternity ward;
3. Age <24 hours;
4. Written informed consent obtained from parent(s) of caregiver(s).
Exclusion criteria
1. Age ≥ 24 hours;
2. Patients with the suspicion of hematologic disorders;
3. Patients with the suspicion of lethal congenital malformations;
4. 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 |
|---|---|
| NTR-new | NL3713 |
| NTR-old | NTR3876 |
| Other | METC Erasmus MC : MEC-2012-474 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |