NCT01167660

Non Invasive Measurement of Coagulation in Term and Preterm Neonates

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: All
• Age: 2 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Coagulation Tests

Interventions

Type	Name	Description
DEVICE	The Thrombo-Monitor (ThM)	Non-invasive measurement of coagulation status and comparison to standard blood coagulation tests. In healthy neonates - immediately after birth, before the administration of vitamin K. Coagulation tests will be done on an umbilical cord blood sample. In sick neonates, coagulation studies will be done according to the medical condition.

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-07-01
• Completion: 2013-12-01
• First posted: 2010-07-22
• Last updated: 2013-02-12

Locations

1 site across 1 country: Israel