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Diagnostic Device

Near-infrared spectroscopy (NIRS) utilization for Premature Birth

N/A

Waitlist Available

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from birth until the end of the birth hospitalization, which would be discharge home or death, whichever occurs first. estimated time is up to 6 months of age.

Awards & highlights

Study Summary

This trial will help determine if near-infrared spectroscopy (NIRS) is a reliable tool to measure oxygen levels in premature babies, and if oxygen levels differ at high altitudes.

Eligible Conditions

Premature Birth

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from birth until the end of the birth hospitalization, which would be discharge home or death, whichever occurs first. estimated time is up to 6 months of age.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from birth until the end of the birth hospitalization, which would be discharge home or death, whichever occurs first. estimated time is up to 6 months of age.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from birth until the end of the birth hospitalization, which would be discharge home or death, whichever occurs first. estimated time is up to 6 months of age. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

cerebral regional oxygen saturation (cRSO2)

Secondary outcome measures

Incidence of Major Complications of Prematurity

Trial Design

1Treatment groups

Experimental Treatment

Group I: Observational ArmExperimental Treatment1 Intervention

Any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Near-infrared spectroscopy (NIRS) utilization

2021

N/A

~20

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Find a Location

Who is running the clinical trial?

University of New MexicoLead Sponsor

372 Previous Clinical Trials

3,528,769 Total Patients Enrolled

4 Trials studying Premature Birth

147 Patients Enrolled for Premature Birth

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any additional participants welcome to join this investigation?

"Affirmative, clinicaltrials.gov reflects that this trial is searching for participants at present. Initially shared on October 1st 2021 and most recently adjusted on October 31st 2022, 100 people are required to be recruited from a single site."

Answered by AI

For whom is this experimental research appropriate?

"This study is seeking 100 neonates aged 0-24 hours old who were born prematurely. In order to qualify, these infants must have required blood transfusions during the monitoring period and be under 32 weeks' gestation at birth."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of NIRS in Preterm Population Born at Altitude

Jessie R. Maxwell 2021. "Use of NIRS in Preterm Population Born at Altitude". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04639583.