Multisite Near-infrared spectroscopy monitoring in newborn infants at risk of circulatory failure
Completed
- Conditions
- circulatory failureshock100075101000401810011954
- Registration Number
- NL-OMON36773
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
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 (<5th percentile for gestational and postnatal age), increased heart rate (>20% above baseline in rest), compromised perfusion (capillary refill > 3 seconds or < 1 second and clinical appearance), oliguria (<0.5 mL/kg/h) and raised lactate or base excess with previously normal pH.
Exclusion Criteria
chromosomal abnormalities
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints:<br /><br>- Cerebral tissue oxygenation as measured with NIRS:<br /><br>o Cerebral rSO2 and FTOE<br /><br>- Mean blood pressure (MABP) as measured with an arterial catheter</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>- Somatic tissue oxygenation as measured with NIRS:<br /><br>o Abdominal rSO2 and FTOE<br /><br>o Renal rSO2 and FTOE<br /><br>- Clinical hemodynamic factors:<br /><br>o heart rate<br /><br>o urinary output<br /><br>o capillary refill<br /><br>- Biochemical hemodynamic factors:<br /><br>o serum lactate<br /><br>o base excess<br /><br>- effect of treatment (volume expansion and/or inotropics) on:<br /><br>o cerebral, abdominal and renal rSO2 and FTOE<br /><br>o MABP<br /><br>- Somatic outcome<br /><br>o Liver function: ASAT/ALAT/LDH/bilirubine<br /><br>o Kidney function: ureum/creatinine<br /><br>- Neurologic outcome:<br /><br>o Will be defined in an extra amendment in the future</p><br>