NCT00544375

Brief Summary

The study quantified functional measures of red blood cell mass and oxygen in neonatal tissues using a non-invasive optical technique: near infrared optical spectroscopy . The study will determine the absolute concentrations of deoxygenated and oxygenated hemoglobin and calculate the tissue hemoglobin saturation and total hemoglobin concentration in viv. Near infrared optical spectroscopy technique use to assessing and defining tissue status in the anemic state and the tissue's response to transfusions, as well as in monitoring hemoglobin and hematocrit without pain or loss of blood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2002

Longer than P75 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

June 1, 2002

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

6.3 years

First QC Date

October 12, 2007

Last Update Submit

October 28, 2022

Conditions

Infant Development

Outcome Measures

Primary Outcomes (1)

  • Infant tissue's response to transfusions

    4 weeks

Study Arms (1)

Neonatal Tissues

Optical measurement neonatal tissues

Device: Optical measurement

Interventions

Optical measurementDEVICE

Optical measurement neonatal tissues

Neonatal Tissues

Eligibility Criteria

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

primary care clinic

You may qualify if:

  • infants weighing less than 1500 grams at birth
  • infants receiving at least one packed red blood cell transfusion

You may not qualify if:

  • neonates who are too unstable as determined by the clinicians for additional human contact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit, University of California Irvine

Orange, California, 92868, United States

Location

Study Officials

  • Feizal Waffarn, M.D

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR

  • Bruce Tromberg, PhD

    Beckman Laser Institute University of California Irvine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Feizal Waffarn, M.D

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 16, 2007

Study Start

June 1, 2002

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)