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Diffuse Correlation Spectroscopy (DCS) for Very Low Birthweight

N/A
Waitlist Available
Led By Terrie E Inder, MD
Research Sponsored by Maria Angela Franceschini
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Premature infants born at <29 weeks GA and <48 hrs of age.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is looking at using a new technique, diffuse correlation spectroscopy (DCS), to monitor the brain health of extremely premature infants. It is hoped that this method will provide detailed information on changes in oxygen consumption and metabolism, and cerebral perfusion. This trial will recruit 100 premature infants and test the feasibility of this new technique.

Eligible Conditions
  • Very Low Birthweight
  • Premature Birth
  • Small for Gestational Age
  • Stroke

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Babies born before 29 weeks of pregnancy and less than 48 hours old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Test the feasibility of DCS CBF continuous measures in ELGA newborn
Secondary outcome measures
Correlation with clinical outcome
Correlation with intraventricular hemorrhage

Trial Design

1Treatment groups
Experimental Treatment
Group I: ELGA groupExperimental Treatment2 Interventions
*Less than 29 weeks Gestational Age (GA) preemies (100) DCS monitoring will be performed for up to 72 hours starting within 2 days after birth. In a subgroup of infants, we will also perform additional measurements with aEEG and FDNIRS. At a second stage we will add Transcranial Doppler Ultrasound (TCD)

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,953 Previous Clinical Trials
2,670,380 Total Patients Enrolled
Maria Angela FranceschiniLead Sponsor
Terrie E Inder, MDPrincipal InvestigatorBrigham and Women's Hospital

Frequently Asked Questions

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

What is the current intake capacity for this research program?

"Affirmative. According to clinicaltrials.gov, this expedition into medical science is currently seeking participants since it was first posted in March 2019 and most recently updated in April 2020. The goal of the research is to enrol 100 patients from one site."

Answered by AI

Are additional participants still being added to this experiment?

"Yes, according to clinicaltrials.gov, this study is accepting new participants since it was first posted on March 15th 2019 and last updated April 26th 2020. 100 patients need to be recruited from one site."

Answered by AI
~17 spots leftby Mar 2025