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.
ID
Bron
Verkorte titel
Aandoening
Adaptation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3713 |
| NTR-old | NTR3876 |
| Ander register | METC Erasmus MC : MEC-2012-474 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |