Plethismographic Perfusion Index in Neonates

September 4, 2016 updated by: Shaare Zedek Medical Center

Examination of Perfusion Index in Term and Preterm Newborns Through Plethismography

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Jerusalem, Israel, 91031
        • Recruiting
        • Ruben Bromiker
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Term and Preterm newborns admitted to the neonatology department

Description

Inclusion Criteria:

  • PDA, PPHN and Normal babies who underwent echocardiography

Exclusion Criteria:

  • Other cardiac diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Term
Normal Term Newborn Intervention: PPG
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
Preterm
Preterm babies admitted to the NICU not suffering from the conditions to be studied Intervention: PPG
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
PDA
Patent Ductus Arteriosus Intervention: PPG
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
PPHN
Persistent Pulmonary Hypertension Intervention: PPG
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Perfusion Index
Time Frame: 5 minutes
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Ruben Bromiker, MD, Shaare Zedek Medical Center, Jerusalem, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

March 1, 2015

First Submitted That Met QC Criteria

March 1, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 181/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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