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Trial record 16 of 24 for:    Recruiting, Not yet recruiting, Available Studies | "Hydrocephalus"

NIRS Monitoring in Premature Infants

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ClinicalTrials.gov Identifier: NCT02601339
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : November 10, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This study is to use advanced near-infrared spectroscopy (NIRS) technology for monitoring cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) in newborns that developed germinal matrix-intraventricular hemorrhage (GM-IVH) and post-hemorrhagic hydrocephalus (PHH) at the bedside. 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 multi-center study at Massachusetts General Hospital (MGH), Brigham and Women's Hospital (BWH) and Boston Children's Hospital (BCH). The Partners Institutional review board (IRB) has approved the protocol to conduct study at BWH and MGH. The IRB protocol at BCH is at the final stage of approval.

Dr. Pei-Yi Lin receives the funding from 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 Procedure: VP shunt

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Study Design

Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Beside Monitor of Cerebral Metabolism in Premature Infants With Intraventricular Hemorrhage and Post-Hemorrhagic Hydrocephalus
Study Start Date : April 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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 who has complications of hydrocephalus secondary to intraventricular hemorrhage and have the potential to receive ETV/CPC and/or VP shunting for the 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
Procedure: VP shunt
ventriculoperitoneal (VP) shunting 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 the 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
Procedure: VP shunt
ventriculoperitoneal (VP) shunting is a surgical procedure to treat infant hydrocephalus


Outcome Measures

Primary Outcome Measures :
  1. FDNIRS-DCS [ Time Frame: 0-2 years old ]
    FDNIRS-DCS measures cerebral blood flow, oxygen saturation and cerebral oxygen of metabolism noninvasively at the patient's bedside. Study "measurement" session will last between 20 and 60 minutes. For each visit, an FDNIRS-DCS monitor is softly placed in contact with the subject's head, which will not cause any discomfort to infants. Repeated measurements in the same location on the head and in different locations will be done. The monitor contains optical fibers (not electrical wires) that are connected to light sources and detectors. Using this monitor, a low-power red light is shined on the subject's skin. The light changes in the brain will be detected by sensitive detectors in which way CBF, CMRO2 and SO2 are then estimated.


Eligibility Criteria

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Ages Eligible for Study:   up to 3 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 with and without GM-IVH less than 3 months old corrected age at first measure.
Criteria
  1. GM-IVH group Inclusion criteria for GM-IVH group: born at gestational age (GA) 24-37 weeks; < 3 months old corrected age at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks post-menstrual age (PMA). Grade I-IV IVH diagnosed by clinical cranial ultrasound.

    Exclusion criteria for GM-IVH group: congenital brain malformation; genetic disorders; severe chromosomal abnormality/syndrome; metabolic or structural abnormality or neoplasm; congenital heart disease; congenital hydrocephalus; imaging evidence of white matter abnormalities or brain lesions other than GM-IVH; infection.

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

    Exclusion criteria for PHH group: congenital brain malformation; genetic disorders; severe chromosomal abnormality/syndrome; metabolic or structural abnormality or neoplasm; congenital heart disease; congenital hydrocephalus; imaging evidence of white matter abnormalities or brain lesions other than IVH-PHH; infection.

  3. HC group Inclusion criteria for HC group: born at gestational age (GA) 24-37 weeks; < 3 months old corrected age 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; genetic disorders; severe chromosomal abnormality/syndrome; known or suspected metabolic disorder or neoplasm; congenital heart disease.

  4. VC group Inclusion criteria for VC group: < 3 months old corrected age at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA). Symptomatic 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; congenital heart disease.

Contacts and Locations

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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
Contact: Pei-Yi Lin, PhD 6177269332 ivylin@nmr.mgh.harvard.edu
Contact: Maria Angela Franceschini, PhD 6177264024 mari@nmr.mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Active, not recruiting
Boston, Massachusetts, United States, 02114
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Pei-Yi Lin, PhD    617-726-9332    ivylin@nmr.mgh.harvard.edu   
Principal Investigator: P. Ellen Grant, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Pei-Yi Lin, PhD    617-726-9332    ivylin@nmr.mgh.harvard.edu   
Principal Investigator: Terrie Inder, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Boston Children’s Hospital
Brigham and Women's Hospital
Investigators
Principal Investigator: Pei-Yi Lin, PhD Massachusetts General Hospital
More Information

Publications:
Fantini S. Frequency-domain multichannel optical detector for noninvasive tissue spectroscopy and oximetry. Optical Engineering 34(1):32, 1995.
Boas DA, Yodh AG. Spatially varying dynamical properties of turbid media probed with diffusing temporal light correlation. J Opt Soc Am A.14(1):192, 1997.
Berghella V. Preterm Birth [Internet]. John Wiley & Sons; 2010. 1 p.
Team RC, editor. R: A Language and Environment for Statistical Computing [Internet]. 2014 ed. R foundation for Statistical Computing, Vienna, Austria; [cited 2014 Sep 3].
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.
Kuznetsova A, Brockhoff PB, Bojesen RH, editors. lmerTest: Tests for random and fixed effects for linear mixed effect models [Internet]. [cited 2015 Jun 2].

Responsible Party: Pei-Yi Lin, Instructor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02601339     History of Changes
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: November 10, 2015
Last Verified: November 2015

Keywords provided by Pei-Yi Lin, Massachusetts General Hospital:
spectroscopy, Near-Infrared

Additional relevant MeSH terms:
Hemorrhage
Premature Birth
Hydrocephalus
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases