Microcirculatory Shock Occurence in Neonatal Adaptation Research (microSONAR).
- Conditions
- Adaptation
- Registration Number
- NL-OMON21064
- Lead Sponsor
- Erasmus MC - Sophia
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
1. Neonates born with a gestational age between 24 weeks and 43 weeks;
2. Admission to the NICU or maternity ward;
Exclusion Criteria
1. Age ≥ 24 hours;
2. Patients with the suspicion of hematologic disorders;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective in this observational study is to determine microcirculatory<br>profile in preterm and term neonates. We would like to determine how the<br>microcirculation changes in time during the phase of adaptation and correlate interand<br>intra-patient variations with clinical signs of maladaptation. Hereby we like to<br>determine what a normal and what an abnormal microcirculatory profile is.
- Secondary Outcome Measures
Name Time Method 1. The relationship between the microcirculation and routinely obtained<br>macrocirculatory parameters;<br /><br>2. The relationship between microcirculatory perfusion (defined by the<br>parameters PVD & MFI) and RBC deformability;<br /><br>3. The relationship between microcirculatory perfusion (defined by the<br>parameters PVD & MFI) and NO metabolism (defined by the parameters urine<br>nitrite and nitrate);<br /><br>4. The effect of oxygen administration on NO-signaling pathways and ROS<br>formation;<br /><br>5. To evaluate if routine treatment options as surfactant administration and red<br>blood cell transfusion improves the microcirculation.