NCT02894970

Brief Summary

To evaluate feasibility of photoplethysmography (PPG) of pulmonary arteries in adults children and neonates and to compare normal controls to premature newborns suffering from patent ductus arteriosus and neonates suffering from pulmonary hypertension.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

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

August 25, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 9, 2016

Status Verified

August 1, 2016

Enrollment Period

9 months

First QC Date

August 25, 2016

Last Update Submit

September 4, 2016

Conditions

Patent Ductus ArteriosusPulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • difference in PPG or pulmonary saturation between conditions

    1 year

Study Arms (6)

Healthy adults

Healthy adults for checking feasibility of Pulmonary PPG

Device: Pulmonary PPG

Healthy children

Healthy children for checking feasibility of Pulmonary PPG

Device: Pulmonary PPG

Healthy neonates

Healthy neonates for checking feasibility of Pulmonary PPG and in order to be a control group for neonates with pulmonary hypertension.

Device: Pulmonary PPG

Healthy preterm neonates

Healthy preterm neonates for checking feasibility of Pulmonary PPG and in order to be a control group for premature neonates with patent ductus arteriosus (PDA).

Device: Pulmonary PPG

Preterm neonates with PDA

Preterm neonates with hemodynamic significant PDA. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns.

Device: Pulmonary PPG

Neonates with pulmonary hypertension

Neonates with pulmonary hypertension. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns.

Device: Pulmonary PPG

Interventions

Pulmonary PPGDEVICE

Five minutes check with a lights source with two wave lengths of infrared and a detector.

Healthy adultsHealthy childrenHealthy neonatesHealthy preterm neonatesNeonates with pulmonary hypertensionPreterm neonates with PDA

Eligibility Criteria

Age1 Day - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteer adults and children, normal newborns, normal premature newborns and newborns suffering from patent ductus arteriosus and pulmonary hypertension

You may qualify if:

  • Hemodynamic stability

You may not qualify if:

  • hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nitzan M, Nitzan I. Pulse oximetry in the pulmonary tissue for the non-invasive measurement of mixed venous oxygen saturation. Med Hypotheses. 2013 Aug;81(2):293-6. doi: 10.1016/j.mehy.2013.04.026. Epub 2013 May 13.

    PMID: 23679994BACKGROUND

MeSH Terms

Conditions

Ductus Arteriosus, PatentHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLung DiseasesRespiratory Tract DiseasesHypertensionVascular Diseases

Study Design

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

Study Record Dates

First Submitted

August 25, 2016

First Posted

September 9, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

September 9, 2016

Record last verified: 2016-08