DCS Study in Extremely Premature Newborns

NCT04367181 | Completed DMC

• 2 other identifiers: 2014P0020221R01HD091067-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To assess if these baseline values are impacted by intermittent hypoxic episodes.
3. 3.To assess if cerebral blood flow disturbances correlate with incidence of intraventricular hemorrhage.
4. 4.Correlate the NIRS-DCS findings with clinical outcome at hospital discharge.

Conditions

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

Keywords

Near-Infrared Spectroscopy; Diffuse Correlation Spectroscopy; Cerebral Blood Flow

Outcome Measures

Primary Outcomes (1)

• Test the feasibility of DCS CBF continuous measures in ELGA newborn

  Test the feasibility of DCS monitoring of cerebral perfusion in extremely premature infants during the first few days of life.

  5 years

Secondary Outcomes (2)

• Correlation with intraventricular hemorrhage

  5 years

• Correlation with clinical outcome

  5 years

Study Arms (1)

ELGA group

EXPERIMENTAL

\*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)

Device: Diffuse Correlation Spectroscopy (DCS); Device: Amplitude Integrated Electroencephalography (aEEG)

Interventions

Amplitude Integrated Electroencephalography (aEEG) DEVICE

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

ELGA group

Diffuse Correlation Spectroscopy (DCS) DEVICE

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

ELGA group

Eligibility Criteria

• Age: 0 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

* Premature infants born at \<29 weeks GA and \<48 hrs of age. * No contraindication to DCS optical sensor placement on the scalp * No major congenital anomalies, * No Complex cyanotic congenital cardiac disease.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Maria Angela Franceschini: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Premature Birth; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Terrie E Inder, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: Approximately 1.5% of infants born every year in the United States are born at an extremely low gestational age (ELGA \<29 weeks GA). As reported in the 2015 VON database, the risk for developing any grade of intraventricular hemorrhage (IVH) in ELGA infants is about 20% and in more than 90% of these cases it occurs during the first three postnatal days. The major risk factor for IVH is the gestational age of the infant with greater immaturity being associated with the highest risk. The degree of prematurity of the infant relates to the immaturity of the vascular bed within the germinal matrix as well as challenges in the regulation of the cerebrovascular circulation. Specifically, increases, decreases and significant fluctuations in cerebral blood flow (CBF) have been shown to play important pathogenic roles in IVH. We are investigating the possibility of using a novel optical method to quantify cerebral perfusion, continuously, at the bedside in the NICU preterm population.

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: April 29, 2020
• Study Start: March 15, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: upon request and at study completion
• Access Criteria: file share

Locations

US (1)