The microcirculation in neonatal adaptation, an observational study.

The microcirculation in neonatal adaptation, an observational study. - The microcirculation in neonates

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39215

Enrollment

365

Registered

2013-12-10

Start date

2013-06-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Microcirculation smallest bloodvessels

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - Neonates born with a gestational age between 24 weeks and 32 weeks and admission to the(NICU) - Neonates born with a gestational age after 37 weeks suffering from asphyxia and admitted to the NICU - Neonates born with a gestational age after 37 weeks and admitted to the maternity ward - Written informed consent obtained from parent(s) of caregiver(s) - Age

Exclusion criteria

Exclusion criteria: - Age >= 24hours - Patients with (the suspicion of) hematologic disorders - Patients with (the suspicion of) lethal congenital malformations - 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 inter- and intra-patient variations with clinical signs of maladaptation. The microcirculation profile consists of: • Microcirculatory perfusion defined by the parameters PVD and MFI • RBC deformability defined by Elongation Index • Cerebral tissue oxygenation defined as cerebral saturation (rScO2), and cerebral fractional tissue oxygen extraction (cFTOE) • NO metabolism measured by urine nitrite and nitrate concentration • Formation of ROS measured by urine malondialdehyde In this study we will examine: • The relationship between the microcirculation and routinely obtained macrocirculatory parameters • The relationship between microcirculatory perfusion (defined by the parameters PVD & MFI) and RBC rheology (defined by the parameters RBC deformability) • The relationship between microcirculatory perfusion (defined by the parameters PVD & MFI) and NO metabolism (defined by the parameters urine nitrite and nitrate) • The effect of oxygen administration on NO-signaling pathways and ROS formation • To evaluate if routine treatment options as surfactant administration and red blood cell transfusion improves the microcirculation	—

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 inter- and intra-patient variations with clinical signs of maladaptation. The microcirculation profile consists of: • Microcirculatory perfusion defined by the parameters PVD and MFI • RBC deformability defined by Elongation Index • Cerebral tissue oxygenation defined as cerebral saturation (rScO2), and cerebral fractional tissue oxygen extraction (cFTOE) • NO metabolism measured by urine nitrite and nitrate concentration • Formation of ROS measured by urine malondialdehyde In this study we will examine: • The relationship between the microcirculation and routinely obtained macrocirculatory parameters • The relationship between microcirculatory perfusion (defined by the parameters PVD & MFI) and RBC rheology (defined by the parameters RBC deformability) • The relationship between microcirculatory perfusion (defined by the parameters PVD & MFI) and NO metabolism (defined by the parameters urine nitrite and nitrate) • The effect of oxygen administration on NO-signaling pathways and ROS formation • To evaluate if routine treatment options as surfactant administration and red blood cell transfusion improves the microcirculation

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Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results