NCT01167660

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2010

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 12, 2013

Status Verified

June 1, 2010

Enrollment Period

3 years

First QC Date

July 5, 2010

Last Update Submit

February 11, 2013

Conditions

Blood Coagulation Tests

Keywords

Coagulation testsNeonatesNon invasive

Outcome Measures

Primary Outcomes (1)

  • Reliability of the non-invasive ThM device.

    From birth up to 1 month

Study Arms (2)

Healthy newborn babies

Healthy newborn babies immediately after birth.

Device: The Thrombo-Monitor (ThM)

Sick newborn babies

Sick newborn babies whose medical condition indicates performing coagulation tests.

Device: The Thrombo-Monitor (ThM)

Interventions

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.

Healthy newborn babiesSick newborn babies

Eligibility Criteria

AgeUp to 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Term and preterm babies born in Meir Medical Center

You may qualify if:

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

You may not qualify if:

  • Congenital anomalies / chromosomal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Study Officials

  • Ita Litmanovitz, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ita Litmanovitz, MD

CONTACT

+972-9-7471554litmani@clalit.org.il

Gisela Laura Sirota, MD

CONTACT

+972-9-7471554gisela.sirota@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2010

First Posted

July 22, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2013

Study Completion

December 1, 2013

Last Updated

February 12, 2013

Record last verified: 2010-06

Locations

IL(1)