NIRS Monitoring in Premature Infants

August 9, 2023 updated by: Pei-Yi Lin, Boston Children's Hospital

Beside Monitor of Cerebral Metabolism in Premature Infants With Intraventricular Hemorrhage and Post-Hemorrhagic Hydrocephalus

This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) at the bedside for newborns with germinal matrix-intraventricular hemorrhage (GM-IVH) and/or post-hemorrhagic hydrocephalus (PHH) in comparison to newborns with hydrocephalus of a different etiology (VC) and healthy controls (HC). We hypothesize that baseline cerebral metabolic dysfunction is a better biomarker for GM-IVH and PHH severity and response to PHH treatment.

This is a Boston Children's Hospital (BCH)-institutional review board(IRB) approved, multi-site study that includes collaboration with Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC). Pei-Yi Lin receives funding from The National Institute of Health (NIH) to support the study and is the overall principal Investigator (PI) overseeing the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction and specific aims:

Germinal matrix-intraventricular hemorrhage (GM-IVH) occurs in 45% of extremely low birth weight (ELBW) premature infants, often leading to long-term neurodevelopmental impairments (NDI). Post-hemorrhagic hydrocephalus (PHH) is a common complication of GM-IVH and increases the risk of major NDI to 75-90%. Currently, the only bedside tool to assess for hemorrhage and monitor for secondary hydrocephalus is ultrasound. Although increasing ventricular size is currently used to determine need for intervention, measures based on cerebral physiology are needed to better determine the impact of the expanding ventricles on individual cerebral metabolism.

Our group has developed advanced FDNIRS-DCS technology for monitoring cerebral oxygen metabolism (CMRO2) in newborns at the bedside. We hypothesize that baseline and evoked cerebral metabolic dysfunctions are better biomarkers for GM-IVH and PHH severity and response to PHH treatment. To test our hypotheses, we will address the following specific aims:

Aim 1: Determine post-natal cerebral hemodynamics and oxygen metabolism trajectories in GM-IVH and PHH neonates with respect to normal controls and differences between PHH infants and infants affected by hydrocephalus due to other pathologies.

We hypothesize that:

  1. Infants with GM-IVH have lower CBF and CMRO2 than healthy controls and the decrease is in proportion to the severity of GM-IVH. (GM-IVH vs HC)
  2. Infants with PHH have lower CBF and CMRO2 than healthy controls. (PHH vs HC)
  3. For infants who developed PHH, the decrease of CBF and CMRO2 is affected by both hemorrhages and the severity of hydrocephalus. (PHH vs VC)

Aim 2: Test the efficacy of cerebral hemodynamics and metabolism in detecting hydrocephalus treatment response in both PHH and VC groups.

We hypothesize that CBF and CMRO2 increase in response to treatment-associated improvements in hydrocephalus but remain depressed when response to treatment is inadequate.

Aim 3: Test the sensitivity of FDNIRS-DCS measured cerebral hemodynamics and oxygen metabolism in predicting developmental outcomes in infants with GM-IVH and PHH. We will assess neurodevelopmental outcomes in all enrolled infants at 5-7, 10-12, and 22-24 months corrected age and correlate with FDNIRS-DCS measurements of CBF and CMRO2, and related quantities with neurodevelopmental outcomes at approximately 5-7, 10-12, and 22-24 months corrected age.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Boston, Massachusetts, United States, 02115
        • Active, not recruiting
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Active, not recruiting
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 year (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The subject population will include premature and full-term neonates that fit criteria for one of the GM-IVH, PHH, HC, or VC groups.

Description

  1. GM-IVH group:

    Inclusion criteria for GM-IVH group: born at gestational age (GA) 24-32 weeks; < 3 months old corrected-GA (cGA) at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks post-menstrual age (PMA). Grade I-III IVH diagnosed by clinical cranial ultrasound or magnetic resonance imaging (MRI).

    Exclusion criteria for GM-IVH group: chromosomal abnormalities known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain metabolism, other than GMH-IVH; central nervous system (CNS) infection.

  2. PHH group:

    Inclusion criteria for PHH group: born at gestational age (GA) 24-37 weeks < 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA). PHH diagnosed by clinical cranial ultrasound or MRI.

    Exclusion criteria for PHH group: chromosomal abnormalities known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain metabolism, other than IVH-PHH; CNS infection. Implanted devices or other devices that preclude the use of MRI.

  3. HC group:

    Inclusion criteria for HC group: born at gestational age (GA) 24-32 weeks; < 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA); Apgar >7 at 5 min.

    Exclusion criteria for HC group: any clinical indication of brain injury or congenital brain malformation; chromosomal abnormality known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection.

  4. VC group:

Inclusion criteria for VC group: < 12 months old cGA at first measure or eligible for measurement within 1 year after the infant reaches 40 weeks age (PMA). Symptomatic hydrocephalus of any etiology or at high risk of developing hydrocephalus of any etiology, except post-hemorrhagic etiology; characterized by abnormal rate of head growth and full anterior fontanelle. Ventricular enlargement diagnosed by ultrasonography or MRI; no signs of IVH.

Exclusion criteria for VC group: known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection. Implanted devices or other devices that preclude the use of MRI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GM-IVH
Premature infants who developed germinal matrix-intraventricular hemorrhage. FDNIRS-DCS measures will be performed up to once a day if clinically feasible.
Posthemorrhagic hydrocephalus (PHH)

Premature infants with complications of hydrocephalus secondary to intraventricular hemorrhage and have the potential to receive endoscopic third ventriculostomy (ETV) with choroid plexus cauterization (CPC) and/or ventriculoperitoneal (VP) shunting for clinical treatment.

FDNIRS-DCS measures will be performed up to once a day if clinically feasible. Additional FDNIRS-DCS measures will be performed on the day of hydrocephalus treatment to monitor the treatment response if clinically feasible. These additional measures are limited to up to four times a day.
Procedure: ETV/CPC
endoscopic third ventriculostomy (ETV) combined with choroid plexus cauterization (CPC) is a surgical procedure to treat infant hydrocephalus
Healthy Control (HC)
Premature infants without diagnosed brain injuries. FDNIRS-DCS measures will be performed up to once a day if clinically feasible.
Ventriculomegaly Control (VC)

Infants who have symptomatic hydrocephalus of any etiology except post-hemorrhagic etiology and have the potential to receive ETV/CPC and/or VP shunting for clinical treatment.

FDNIRS-DCS measures will be performed up to once a day if clinically feasible. Additional FDNIRS-DCS measures will be performed on the day of hydrocephalus treatment to monitor the treatment response if clinically feasible. These additional measures are limited to up to four times a day.
Procedure: ETV/CPC
endoscopic third ventriculostomy (ETV) combined with choroid plexus cauterization (CPC) is a surgical procedure to treat infant hydrocephalus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CMRO2
Time Frame: 0-2 years old
The primary outcomes are FDNIRS-DCS-measured CMRO2 trajectory.
0-2 years old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Pei-Yi Lin, PhD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimated)

November 10, 2015

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P001713
  • 1K99HD083512-01 (U.S. NIH Grant/Contract)
  • P00014042 (Other Identifier: Boston Children's Hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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