DCS Study in Extremely Premature Newborns

Summary

The researchers are attempting to improve the cerebral monitoring of extremely low gestational age (ELGA) infants, such that in the future, real-time monitoring will be possible, to aid clinicians in management of these infants. The researchers wish to establish a new NIRS device, diffuse correlation spectroscopy (DCS), as a safe, noninvasive and informative bedside tool for assessing and monitoring brain health in ELGA infants during the first few days of life. It is hoped that this method will provide detailed information on changes in oxygen consumption and metabolism, and cerebral perfusion. This technique will have wide applicability, but for this research study, the researchers wish to focus on the effect of blood flow instabilities, intermittent hypotension and hypoxic episodes, pressure passive CBF periods, and hypoperfusion on the preterm brain during the first days of life, and the relationship with incidence of intraventricular hemorrhage (IVH). The researchers aim to recruit 100 premature infants to obtain data to:

1. Test the feasibility of NIRS-DCS to monitor cerebral activity, perfusion and oxygen consumption in extremely premature infants during the first week of life.
2. To assess if these baseline values are impacted by intermittent hypoxic episodes.
3. To assess if cerebral blood flow disturbances correlate with incidence of intraventricular hemorrhage.
4. Correlate the NIRS-DCS findings with clinical outcome at hospital discharge.

Conditions

• Premature Birth
• Extremely Low Birth Weight
• Infant, Small for Gestational Age
• Intracerebral Hemorrhage

Interventions

DEVICE

Diffuse Correlation Spectroscopy (DCS)

Diffuse correlation spectroscopy uses light in the near infrared spectral region to quantify non-invasively cerebral blood flow. The DCS device will be use to monitor blood flow changes over time in all ELGA enrolled babies

DEVICE

Amplitude Integrated Electroencephalography (aEEG)

Amplitude Integrated Electroencephalography like EEG it is used clinically to monitor brain function in intensive care settings over longer periods of time. aEEG data will be correlated with CBF variation over time

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Maria Angela Franceschini

  lead OTHER

Principal Investigators

• Terrie E Inder, MD · Brigham and Women's Hospital

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

0 Hours

Max Age

72 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-15

Primary Completion

2023-05-31

Completion

2023-05-31

Countries

• United States

Study Locations