Plethismographic Perfusion Index in Neonates

• Sponsor: Shaare Zedek Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02380040
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus; Persistent Pulmonary Hypertension of the Newborn	Device: PPG

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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Examination of Perfusion Index in Term and Preterm Newborns Through Plethismography
• Study Start Date: Mar 1, 2015
• Anticipated Primary Completion Date: Nov 1, 2016
• Anticipated Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Perfusion Index [5 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 3 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• PDA, PPHN and Normal babies who underwent echocardiography

Exclusion Criteria:

• Other cardiac diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruben Bromiker	Jerusalem		Israel	91031

Sponsors and Collaborators

• Shaare Zedek Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shaare Zedek Medical Center
• ClinicalTrials.gov Identifier: NCT02380040
• Other Study ID Numbers: 181/14
• First Posted: Mar 5, 2015
• Last Update Posted: Sep 7, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Hypertension, Pulmonary; Persistent Fetal Circulation Syndrome; Ductus Arteriosus, Patent

Study Results

No Results Posted as of Sep 7, 2016