Non Invasive Measurement of Coagulation in Term and Preterm Neonates
- Conditions
- Blood Coagulation Tests
- Interventions
- Device: The Thrombo-Monitor (ThM)
- Registration Number
- NCT01167660
- Lead Sponsor
- Meir Medical Center
- Brief Summary
The purpose of this study is to assess the reliability of a new non-invasive device to assess the blood coagulation status among term and preterm babies.
- Detailed Description
Coagulation abnormalities among neonates aren't common - but can be life threatening. Testing the coagulation system in small babies involves drawing significant amounts of blood (especially in premature babies). Non-invasive testing can help assess and treat term and preterm neonates at risk. Recently, a non-invasive device to assess the blood coagulation status was developed - The Thrombo-Monitor (ThM). The objective of this study is to assess the reliability of this new non-invasive device among term and preterm babies by comparing the result of the ThM reading to coagulation analysis from blood.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Newborn babies - term and preterm
- Written parental informed consent
- Congenital anomalies / chromosomal abnormalities
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy newborn babies The Thrombo-Monitor (ThM) Healthy newborn babies immediately after birth. Sick newborn babies The Thrombo-Monitor (ThM) Sick newborn babies whose medical condition indicates performing coagulation tests.
- Primary Outcome Measures
Name Time Method Reliability of the non-invasive ThM device. From birth up to 1 month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Meir Medical Center
🇮🇱Kfar-Saba, Israel