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NCT02380040 Clinical Trial

Plethismographic Perfusion Index in Neonates

Patent Ductus Arteriosus Clinical Trial

Official title:
Examination of Perfusion Index in Term and Preterm Newborns Through Plethismography

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02380040
Other study ID # 181/14
Secondary ID
Status Recruiting
Phase N/A
First received March 1, 2015
Last updated September 4, 2016
Start date March 2015
Est. completion date March 2017

Study information
Verified date August 2016
Source Shaare Zedek Medical Center
Contact Ruben Bromiker, MD
Phone 972508685154
Email bromi@szmc.org.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial Summary

Photoplethismography will be measured and compared in newborns suffering from patent ductus arteriosus and normal controls.

Description:

Newborn babies admitted to the NICU and well baby will be connected to a specially designed photoplethismograph (PPG). Right hand (pre ductal), and and one of the legs (postductal) values will be compared, based on the formula Delta amplitude of PPG / baseline absorption (perfusion index (PI)). Normal values will be defined in healthy term and preterm babies, and clinical conditions in which the PI is expected to change (Patent Ductus Artheriosus, Persistent pulmonary hypertension of the newborn)will be compared with these normal values.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 2017
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 3 Months
Eligibility Inclusion Criteria:

- PDA, PPHN and Normal babies who underwent echocardiography

Exclusion Criteria:

- Other cardiac diseases

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• PPG
A PPG device will be applied to subjects in the right hand, left hand and one of the legs. Data will be recorded into a computer software

Locations
Country Name City State
Israel Ruben Bromiker Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perfusion Index 5 minutes No
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