NIRS Monitoring in Premature Infants

Launched by BOSTON CHILDREN'S HOSPITAL · Nov 6, 2015

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to monitor brain health in premature infants who have experienced bleeding in the brain, known as germinal matrix-intraventricular hemorrhage (GM-IVH), or those with post-hemorrhagic hydrocephalus (PHH). The study uses advanced technology to measure blood flow and oxygen use in the brain at the bedside. Researchers believe that understanding how these infants' brains are functioning can help them assess the severity of their conditions and how well treatments are working.

To be eligible for this study, infants must be between 24 to 37 weeks old at birth and less than three months old at the time of their first measurement. There are specific criteria for different groups: those with GM-IVH and PHH will be included if they have been diagnosed with these conditions through imaging tests. Healthy infants will also be part of the study, provided they have no signs of brain injury. Participants can expect to undergo non-invasive monitoring at the hospital, helping doctors learn more about how to care for these vulnerable babies. This trial is being conducted with the support of several hospitals and is funded by the National Institutes of Health.

Gender

ALL

Eligibility 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.