Non Invasive Measurement of Coagulation in Term and Preterm Neonates

• Conditions: Blood Coagulation Tests

• 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.

Study Timeline

• Status Verified: 2010-06
• Study Start: 2010-07
• Study First Submitted: 2010-07-05
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-12
• Primary Completion: 2013-07
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Newborn babies - term and preterm
• Written parental informed consent

Exclusion Criteria

• Congenital anomalies / chromosomal abnormalities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reliability of the non-invasive ThM device.	From birth up to 1 month

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar-Saba, Israel