NIRS Monitoring in Premature Infants

NCT02601339 | Recruiting

• 3 other identifiers: 2014P0017131K99HD083512-01P00014042
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 3

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.

Conditions

Hemorrhage; Premature Infants; Newborn; Hydrocephalus

Keywords

spectroscopy, Near-Infrared

Outcome Measures

Primary Outcomes (1)

• CMRO2

  The primary outcomes are FDNIRS-DCS-measured CMRO2 trajectory.

  0-2 years old

Study Arms (4)

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

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

Interventions

ETV/CPC PROCEDURE

endoscopic third ventriculostomy (ETV) combined with choroid plexus cauterization (CPC) is a surgical procedure to treat infant hydrocephalus

Posthemorrhagic hydrocephalus (PHH); Ventriculomegaly Control (VC)

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may not qualify if:

• PHH group:
• HC group:
• VC group:

Sponsors & Collaborators

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

Study Sites (3)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

ACTIVE NOT RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

ACTIVE NOT RECRUITING

Related Publications (12)

• Fantini S. Frequency-domain multichannel optical detector for noninvasive tissue spectroscopy and oximetry. Optical Engineering 34(1):32, 1995.

  BACKGROUND

• Boas DA, Campbell LE, Yodh AG. Scattering and Imaging with Diffusing Temporal Field Correlations. Phys Rev Lett. 1995 Aug 28;75(9):1855-1858. doi: 10.1103/PhysRevLett.75.1855. No abstract available.

  PMID: 10060408 BACKGROUND

• Wilson-Costello D, Friedman H, Minich N, Fanaroff AA, Hack M. Improved survival rates with increased neurodevelopmental disability for extremely low birth weight infants in the 1990s. Pediatrics. 2005 Apr;115(4):997-1003. doi: 10.1542/peds.2004-0221.

  PMID: 15805376 BACKGROUND

• Roche-Labarbe N, Carp SA, Surova A, Patel M, Boas DA, Grant PE, Franceschini MA. Noninvasive optical measures of CBV, StO(2), CBF index, and rCMRO(2) in human premature neonates' brains in the first six weeks of life. Hum Brain Mapp. 2010 Mar;31(3):341-52. doi: 10.1002/hbm.20868.

  PMID: 19650140 BACKGROUND

• Berghella V. Preterm Birth [Internet]. John Wiley & Sons; 2010. 1 p.

  BACKGROUND

• Horbar JD, Carpenter JH, Badger GJ, Kenny MJ, Soll RF, Morrow KA, Buzas JS. Mortality and neonatal morbidity among infants 501 to 1500 grams from 2000 to 2009. Pediatrics. 2012 Jun;129(6):1019-26. doi: 10.1542/peds.2011-3028. Epub 2012 May 21.

  PMID: 22614775 BACKGROUND

• Bates D, Maechler M, Bolker B, Walker S, editors. me4: Linear mixed-effects models using Eigen and S4 [Internet]. [cited 2015 Jun 2].

  BACKGROUND

• Volpe JJ. Neurology of the Newborn. Elsevier Health Sciences; 2008. 1 p.

  BACKGROUND

• Volpe JJ. Brain injury in premature infants: a complex amalgam of destructive and developmental disturbances. Lancet Neurol. 2009 Jan;8(1):110-24. doi: 10.1016/S1474-4422(08)70294-1.

  PMID: 19081519 BACKGROUND

• Del Bigio MR. Cell proliferation in human ganglionic eminence and suppression after prematurity-associated haemorrhage. Brain. 2011 May;134(Pt 5):1344-61. doi: 10.1093/brain/awr052. Epub 2011 Apr 7.

  PMID: 21478186 BACKGROUND

• Fantini S, Franceschini MA, Fishkin JB, Barbieri B, Gratton E. Quantitative determination of the absorption spectra of chromophores in strongly scattering media: a light-emitting-diode based technique. Appl Opt. 1994 Aug 1;33(22):5204-13. doi: 10.1364/AO.33.005204.

  PMID: 20935909 BACKGROUND

• Lin PY, Roche-Labarbe N, Dehaes M, Carp S, Fenoglio A, Barbieri B, Hagan K, Grant PE, Franceschini MA. Non-invasive optical measurement of cerebral metabolism and hemodynamics in infants. J Vis Exp. 2013 Mar 14;(73):e4379. doi: 10.3791/4379.

  PMID: 23524854 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Premature Birth; Hydrocephalus

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pei-Yi Lin, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Yi Lin, PhD

CONTACT

ivy.lin@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 10, 2015
• Study Start: April 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (3)