Non Invasive Measurement of Coagulation in Term and Preterm Neonates

Clalit Health Services

Status: Unknown

Conditions: Blood Coagulation Tests

Treatments: Device: The Thrombo-Monitor (ThM)

Study type: Observational

Funder types: Other

Identifiers

NCT01167660

Pag-ThM2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 2 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Congenital anomalies / chromosomal abnormalities

Trial design

120 participants in 2 patient groups

Healthy newborn babies

Description:

Healthy newborn babies immediately after birth.

Treatment:

Device: The Thrombo-Monitor (ThM)

Sick newborn babies

Description:

Sick newborn babies whose medical condition indicates performing coagulation tests.

Treatment:

Device: The Thrombo-Monitor (ThM)