NCT02380040

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 7, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

March 1, 2015

Last Update Submit

September 4, 2016

Conditions

Patent Ductus ArteriosusPersistent Pulmonary Hypertension of the Newborn

Outcome Measures

Primary Outcomes (1)

  • Perfusion Index

    5 minutes

Study Arms (4)

Term

Normal Term Newborn Intervention: PPG

Device: PPG

Preterm

Preterm babies admitted to the NICU not suffering from the conditions to be studied Intervention: PPG

Device: PPG

PDA

Patent Ductus Arteriosus Intervention: PPG

Device: PPG

PPHN

Persistent Pulmonary Hypertension Intervention: PPG

Device: PPG

Interventions

PPGDEVICE

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

PDAPPHNPretermTerm

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Term and Preterm newborns admitted to the neonatology department

You may qualify if:

  • PDA, PPHN and Normal babies who underwent echocardiography

You may not qualify if:

  • Other cardiac diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruben Bromiker

Jerusalem, 91031, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29943734DERIVED

MeSH Terms

Conditions

Ductus Arteriosus, PatentPersistent Fetal Circulation Syndrome

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesInfant, Newborn, Diseases

Study Officials

  • Ruben Bromiker, MD

    Shaare Zedek Medical Center, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruben Bromiker, MD

CONTACT

972508685154bromi@szmc.org.il

Itamar Nitzan, MD

CONTACT

972507414998itamarnitzan@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2015

First Posted

March 5, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2016

Study Completion

March 1, 2017

Last Updated

September 7, 2016

Record last verified: 2016-08

Locations

IL(1)