Third Opinion | Clinical Trial Patient Recruitment Strategies

NIRS Monitoring in Premature Infants

Summary

Third Opinion Trial Synopsis:
This study is looking at how a special technology can be used to measure blood flow and oxygen in the brains of newborn babies. The researchers are comparing babies with bleeding in their brains or swelling in their heads to healthy babies. They think that problems with how the brain uses energy might be a better way to tell how bad the bleeding or swelling is and how well treatment is working. The study has been approved by a hospital review board and is being done at different hospitals. Pei-Yi Lin is in charge of the study and is getting funding from the National Institute of Health.

*Third Opinion AI Generated Synopsis

Trial 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.

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Enrollment Criteria

Third Opinion Criteria Synopsis

This is a study that focuses on four groups of babies. The first group is called GM-IVH group. Babies in this group were born between 24 and 32 weeks of pregnancy. They should be less than 3 months old or can be measured within 12 weeks after they turn 40 weeks old. These babies should have been diagnosed with grades I-III IVH (intraventricular hemorrhage) using a cranial ultrasound or MRI. Babies with certain conditions like chromosomal abnormalities, metabolic disorders, or CNS infection are not included in this group.The second group is called PHH group. Babies in this group were born between 24 and 37 weeks of pregnancy. They should be less than 3 months old or can be measured within 12 weeks after they turn 40 weeks old. These babies should have been diagnosed with PHH (post-hemorrhagic hydrocephalus) using a cranial ultrasound or MRI. Babies with certain conditions like chromosomal abnormalities, metabolic disorders, or CNS infection are not included in this group. They should not have any implanted devices or other devices that prevent the use of MRI.The third group is called HC group. Babies in this group were born between 24 and 32 weeks of pregnancy. They should be less than 3 months old or can be measured within 12 weeks after they turn 40 weeks old. These babies should have an Apgar score higher than 7 at 5 minutes after birth. Babies with brain injuries, chromosomal abnormalities, metabolic disorders, or critical congenital heart disease are not included in this group.The fourth group is called VC group. Babies in this group can be less than 12 months old or can be measured within 1 year after they turn 40 weeks old. These babies should have symptomatic hydrocephalus or be at high risk of developing hydrocephalus. They should not have any signs of IVH (intraventricular hemorrhage). Babies with certain conditions like metabolic disorders or CNS infection are not included in this group. They should not have implanted devices or other devices that prevent the use of MRI.

*Third Opinion AI Generated Synopsis

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.

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.

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.

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.