Microcirculatory Shock Occurence in Neonatal Adaptation Research (microSONAR).

The Microcirculatioin in neonatal adaptation.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21064

Enrollment

400

Registered

2013-02-28

Start date

2013-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adaptation

Interventions

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.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactH.A. Elteren, van

Erasmus MC - Sophia Children’s Hospital Department of Pediatrics Room SK-2210 Dr. Molewaterplein 60 Postbus 2060

h.vanelteren@erasmusmc.nl+31 (0)10 7036015

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)