Multisite Near-infrared spectroscopy monitoring in newborn infants at risk of circulatory failure

Multisite Near-infrared spectroscopy monitoring in newborn infants at risk of circulatory failure - NIRS and circulatory failure in newborns

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36773

Enrollment

Registered

2011-06-22

Start date

2011-09-21

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

circulatory failure shock

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: newborns admitted to the NICU of the University Medical Center Groningen at risk of circulatory failure due to patent ductus arteriosus, clinical sepsis or acyanotic congenital heart disease. Risk of circulatory failure will be defined as at least two of the following events: hypotension (20% above baseline in rest), compromised perfusion (capillary refill > 3 seconds or

Exclusion criteria

Exclusion criteria: chromosomal abnormalities

Design outcomes

Primary

Measure	Time frame
Primary endpoints: - Cerebral tissue oxygenation as measured with NIRS: o Cerebral rSO2 and FTOE - Mean blood pressure (MABP) as measured with an arterial catheter	—

Secondary

Measure	Time frame
Secondary endpoints: - Somatic tissue oxygenation as measured with NIRS: o Abdominal rSO2 and FTOE o Renal rSO2 and FTOE - Clinical hemodynamic factors: o heart rate o urinary output o capillary refill - Biochemical hemodynamic factors: o serum lactate o base excess - effect of treatment (volume expansion and/or inotropics) on: o cerebral, abdominal and renal rSO2 and FTOE o MABP - Somatic outcome o Liver function: ASAT/ALAT/LDH/bilirubine o Kidney function: ureum/creatinine - Neurologic outcome: o Will be defined in an extra amendment in the future	—

Measure

Time frame

Secondary endpoints: - Somatic tissue oxygenation as measured with NIRS: o Abdominal rSO2 and FTOE o Renal rSO2 and FTOE - Clinical hemodynamic factors: o heart rate o urinary output o capillary refill - Biochemical hemodynamic factors: o serum lactate o base excess - effect of treatment (volume expansion and/or inotropics) on: o cerebral, abdominal and renal rSO2 and FTOE o MABP - Somatic outcome o Liver function: ASAT/ALAT/LDH/bilirubine o Kidney function: ureum/creatinine - Neurologic outcome: o Will be defined in an extra amendment in the future

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Countries

Netherlands

Outcome results