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Microcirculatory Shock Occurence in Neonatal Adaptation Research (microSONAR).


- candidate number14449
- NTR NumberNTR3876
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-feb-2013
- Secondary IDsMEC-2012-474 METC Erasmus MC
- Public TitleMicrocirculatory Shock Occurence in Neonatal Adaptation Research (microSONAR).
- Scientific TitleThe Microcirculatioin in neonatal adaptation.
- ACRONYMmicroSONAR
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedAdaptation
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-apr-2013
- planned closingdate1-apr-2015
- Target number of participants400
- InterventionsThis 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.
- Primary outcomeThe 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 outcome1. 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.
- TimepointsCytoCam 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.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. H.A. Elteren, van
- CONTACT for SCIENTIFIC QUERIESDrs. H.A. Elteren, van
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Sophia Children's Hospital
- PublicationsN/A
- Brief summaryAdaptation 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.
- Main changes (audit trail)
- RECORD28-feb-2013 - 11-mrt-2013


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