NCT00989859

Brief Summary

The researchers want to determine if ambient light, plethysmographic , can monitor reliably heart rate, respiration rate and oxygen saturation in infant patients in a hospital setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

October 2, 2009

Last Update Submit

October 28, 2022

Conditions

Child Development

Keywords

monitoring

Outcome Measures

Primary Outcomes (1)

  • ambient light, PPG can monitor reliably heart rate, respiration rate and oxygen saturation (SpO2)

    24 hours

Study Arms (1)

Plethysmographic monitoring

Plethysmographic monitoring

Device: Plethysmographic monitoring

Interventions

Plethysmographic monitoringDEVICE

Plethysmographic monitoring

Plethysmographic monitoring

Eligibility Criteria

Age1 Minute - 1 Week
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

infant

You may qualify if:

  • infant in NICU at CHOC hospital

You may not qualify if:

  • non-infant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHOC

Orange, California, 92868, United States

Location

Study Officials

  • Stuart Nelson, MD

    Beckman Laser Institute University of California Irvine

    STUDY DIRECTOR

  • William Verkruysse, PhD

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Willem Verkruysse, Ph.D., Associate Specialist

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 6, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)