Non Invasive Measurement of Coagulation in Term and Preterm Neonates

Blood Coagulation Tests Clinical Trial

Official title:

Non Invasive Measurement of Coagulation in Term and Preterm Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01167660
• Other study ID #: Pag-ThM2
• Status: Recruiting
• Phase: N/A
• First received: July 5, 2010
• Last updated: February 11, 2013
• Start date: July 2010
• Est. completion date: December 2013

Study information

• Verified date: June 2010
• Source: Meir Medical Center
• Contact: Ita Litmanovitz, MD
• Phone: +972-9-7471554
• Email: litmani[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Months

Eligibility

Inclusion Criteria:

• Newborn babies - term and preterm

• Written parental informed consent

Exclusion Criteria:

• Congenital anomalies / chromosomal abnormalities

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Coagulation Tests

Intervention

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.

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability of the non-invasive ThM device.		From birth up to 1 month	No