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NIRS Monitoring in Premature Infants

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ClinicalTrials.gov Identifier: NCT02601339
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : August 1, 2022
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Pei-Yi Lin, Boston Children's Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Hemorrhage Premature Infants Newborn Hydrocephalus Procedure: ETV/CPC

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 Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Beside Monitor of Cerebral Metabolism in Premature Infants With Intraventricular Hemorrhage and Post-Hemorrhagic Hydrocephalus
Actual Study Start Date : April 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. CMRO2 [ Time Frame: 0-2 years old ]
    The primary outcomes are FDNIRS-DCS-measured CMRO2 trajectory.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   0 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
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.
Criteria

  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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601339


Contacts
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Contact: Pei-Yi Lin, PhD ivy.lin@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Pei-Yi Lin, PhD       Ivy.Lin@childrens.harvard.edu   
Principal Investigator: Pei-Yi Lin, PhD         
Brigham and Women's Hospital Active, not recruiting
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston Children's Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Pei-Yi Lin, PhD Boston Children's Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
Fantini S. Frequency-domain multichannel optical detector for noninvasive tissue spectroscopy and oximetry. Optical Engineering 34(1):32, 1995.
Berghella V. Preterm Birth [Internet]. John Wiley & Sons; 2010. 1 p.
Bates D, Maechler M, Bolker B, Walker S, editors. me4: Linear mixed-effects models using Eigen and S4 [Internet]. [cited 2015 Jun 2].
Volpe JJ. Neurology of the Newborn. Elsevier Health Sciences; 2008. 1 p.

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Responsible Party: Pei-Yi Lin, Assistant Professor, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02601339    
Other Study ID Numbers: 2014P001713
1K99HD083512-01 ( U.S. NIH Grant/Contract )
P00014042 ( Other Identifier: Boston Children's Hospital )
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pei-Yi Lin, Boston Children's Hospital:
spectroscopy, Near-Infrared
Additional relevant MeSH terms:
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Hydrocephalus
Premature Birth
Hemorrhage
Pathologic Processes
Obstetric Labor, Premature
 Obstetric Labor Complications
Pregnancy Complications
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases