Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy newborn babies | Healthy newborn babies immediately after birth. |
| |
| Sick newborn babies | Sick newborn babies whose medical condition indicates performing coagulation tests. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Thrombo-Monitor (ThM) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reliability of the non-invasive ThM device. | From birth up to 1 month |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Term and preterm babies born in Meir Medical Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ita Litmanovitz, MD | Contact | +972-9-7471554 | litmani@clalit.org.il | |
| Gisela Laura Sirota, MD | Contact | +972-9-7471554 | gisela.sirota@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Ita Litmanovitz, MD | Meir Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Recruiting | Kfar Saba | Israel |
Not provided
Not provided
Not provided
Not provided
|