Blood Coagulation Tests
Conditions
Keywords
Coagulation tests, Neonates, Non invasive
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.
Interventions
DEVICEThe 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.
Sponsors
Meir Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
No
Inclusion criteria
* Newborn babies - term and preterm * Written parental informed consent
Exclusion criteria
* Congenital anomalies / chromosomal abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reliability of the non-invasive ThM device. | From birth up to 1 month |
Countries
Israel
Contacts
Primary ContactIta Litmanovitz, MD
Backup ContactGisela Laura Sirota, MD
Outcome results
None listed