Monitoring brain blood flow and oxygen in premature infants
Beside Monitor of Cerebral Metabolism in Premature Infants With Intraventricular Hemorrhage and Post-Hemorrhagic Hydrocephalus
This study is trying to see if monitoring blood flow and oxygen in the brains of premature infants with certain types of brain bleeding can help doctors understand how serious their condition is and how well treatments are working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 0 Months to 12 Months |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT02601339 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include premature infants born between 24-37 weeks gestational age who are diagnosed with GM-IVH or PHH.
Not a fit: Patients with chromosomal abnormalities, congenital hydrocephalus, or other significant brain lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for premature infants suffering from severe brain hemorrhages.
How similar studies have performed: Other studies utilizing similar monitoring technologies have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.