Monitoring brain blood flow and oxygen in premature infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study utilizes advanced frequency domain near-infrared spectroscopy coupled with diffuse correlation spectroscopy (FDNIRS-DCS) to monitor cerebral blood flow and oxygen metabolism in premature infants with germinal matrix-intraventricular hemorrhage (GM-IVH) and post-hemorrhagic hydrocephalus (PHH). The study compares these infants to those with hydrocephalus from other causes and healthy controls. The goal is to determine if cerebral metabolic dysfunction can serve as a better biomarker for assessing the severity of GM-IVH and PHH and the effectiveness of treatments. The study is multi-site and involves collaboration with several prominent hospitals in Boston.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Pei-Yi Lin, PhD — Boston Children's Hospital
• Study coordinator: Pei-Yi Lin, PhD
• Email: ivy.lin@childrens.harvard.edu

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.