Bedside light-based monitoring of brain blood flow in premature babies with brain bleeding

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for babies with bleeding in the brain (GM-IVH) or fluid build-up after such bleeding (PHH). It also takes babies with fluid build-up from other causes and healthy premature babies for comparison.

Age

0 Months to 12 Months. Bleeding, PHH and healthy groups: born at 24-32 weeks (PHH: 24-37 weeks) and under 3 months corrected age at first measure. Other fluid build-up group: under 12 months corrected age.

Sex

All

Disease stage

Bleeding group: Grade I-III IVH. PHH group: fluid build-up after bleeding. Other group: hydrocephalus with symptoms, or at high risk, from any cause other than bleeding. Healthy group: Apgar >7 at 5 min. Diagnosis by cranial ultrasound or MRI.

Main reasons for not taking part

• Known chromosome abnormality (not for the other fluid build-up group)
• Known or suspected metabolic disorder or tumour
• Critical heart disease present from birth
• Brain or spinal cord infection (CNS infection)
• Implanted devices that prevent MRI (PHH and other fluid build-up groups)

The registry criteria, word for word

What the trial wants to find out

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.

The 4 groups in the trial

• 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.

  Treatment: 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.

  Treatment: ETV/CPC