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Plethismographic Perfusion Index in Neonates

Examination of Perfusion Index in Term and Preterm Newborns Through Plethismography

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02380040
Enrollment
100
Registered
2015-03-05
Start date
2015-03-31
Completion date
2017-03-31
Last updated
2016-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus, Persistent Pulmonary Hypertension of the Newborn

Brief summary

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

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.

Interventions

DEVICEPPG

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

Sponsors

Shaare Zedek Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
Yes

Inclusion criteria

* PDA, PPHN and Normal babies who underwent echocardiography

Exclusion criteria

* Other cardiac diseases

Design outcomes

Primary

MeasureTime frame
Perfusion Index5 minutes

Countries

Israel

Contacts

Primary ContactRuben Bromiker, MD
bromi@szmc.org.il972508685154
Backup ContactItamar Nitzan, MD
itamarnitzan@gmail.com972507414998

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026