Plethismographic Perfusion Index in Neonates

NCT ID: NCT02380040

Last Updated: 2016-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Patent Ductus Arteriosus Persistent Pulmonary Hypertension of the Newborn

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Term

Normal Term Newborn Intervention: PPG

PPG

Intervention Type DEVICE

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

PPG

Intervention Type DEVICE

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

PPG

Intervention Type DEVICE

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

PPG

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* PDA, PPHN and Normal babies who underwent echocardiography

Exclusion Criteria

* Other cardiac diseases
Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ruben Bromiker, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center, Jerusalem, Israel

Locations

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Ruben Bromiker

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ruben Bromiker, MD

Role: CONTACT

972508685154

Itamar Nitzan, MD

Role: CONTACT

972507414998

Facility Contacts

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Ruben Bromiker, MD

Role: primary

972508685154

Itamar Nitzan, MD

Role: backup

972507414998

References

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Nitzan I, Hammerman C, Fink D, Nitzan M, Koppel R, Bromiker R. The effect of patent ductus arteriosus on pre-ductal and post-ductal perfusion index in preterm neonates. Physiol Meas. 2018 Jul 20;39(7):075006. doi: 10.1088/1361-6579/aacf25.

Reference Type DERIVED
PMID: 29943734 (View on PubMed)

Other Identifiers

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181/14

Identifier Type: -

Identifier Source: org_study_id

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