Plethismographic Perfusion Index in Neonates

• Conditions: Persistent Pulmonary Hypertension of the Newborn; Patent Ductus Arteriosus

• Registration Number: NCT02380040
• Lead Sponsor: Shaare Zedek Medical Center

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-01
• Study First Submitted QC: 2015-03-01
• Study First Posted: 2015-03-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-09-04
• Last Update Posted: 2016-09-07
• Primary Completion: 2016-11
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• PDA, PPHN and Normal babies who underwent echocardiography

Exclusion Criteria

• Other cardiac diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perfusion Index	5 minutes

Trial Locations

Locations (1)

Ruben Bromiker; 🇮🇱 Jerusalem, Israel