Intraventricular Hemorrhage Clinical Trial
— SQUIBOfficial title:
Sonographic Quantification of Venous Circulation in the Preterm Brain
NCT number | NCT04535375 |
Other study ID # | SQUIB2020 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2021 |
Est. completion date | May 16, 2024 |
Verified date | May 2024 |
Source | Universitair Ziekenhuis Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to develop an accessible, reproducible ultrasound tool for objective clinical measurement of brain circulation in preterm infants in order to identify infants being at risk for preterm brain injury at an early stage. In the future, the results of this study might be useful to select those infants for early interventions aimed at preventing brain injury. In this study we will identify the normative values of the internal cerebral vein velocity in a reference cohort of stable preterm infants. This stable group of preterm infants is defined as all preterm infants with a birth weight appropriate for gestational age, and without major complications (such as a severe intracranial hemorrhage, severe hemodynamical instability, birth asphyxia) or major congenital malformations. In this group we will identify subgroups based on moments of clinical instability (sepsis, temporary hypotension, NEC, need for invasive respiratory support) or based on outcome parameters (IVH, PVL, developmental outcomes)
Status | Completed |
Enrollment | 47 |
Est. completion date | May 16, 2024 |
Est. primary completion date | May 16, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 3 Hours |
Eligibility | Inclusion Criteria: - Preterm infant with a gestational age below 32 0/7 weeks - birth weight between the 3rd and 97th percentile. - No cerebral Doppler abnormalities on prenatal ultrasound (i.e. brain sparing) Exclusion Criteria: - Brain vessel anomaly - Major congenital malformation - No parental consent - IVH > grade 2 (Papile classification or structural brain abnormalities on the first ultrasound - Severe hemodynamic instability in the first 6 hours of life requiring treatment with inotropes. |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Brussel | Brussel | Brussels Capital |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Normative values of internal cerebral vein velocity | Determination of normative values of ICV velocity and their range in the first weeks of life in stable preterm infants. The Doppler measurements will be performed at several moments after birth: day 0, 1, 2, 3, 7, 14, 21, etc untill 36 weeks gestational age.
For this purpose we will calculate the Maximum velocity (cm/s), the mean velocity (cm/s) and the variability (according to Ikeda et al) of the flow pattern in the Internal Cerebral Vein. These velocities will be plotted in an attempt to discover longitudinal normative values in this cohort of 50 preterm infants. |
2-3 years | |
Secondary | Short-term outcome: cerebral complications in the neonatal phase | Relation of ICV flow with IVH grade 2 or more (according to the Papile classification), periventricular leukomalacia, ventriculomegaly, white matter disease, selective neuronal necrosis assessed by routinely performed MRI scan of the brain at term equivalent age. | 2-3 years | |
Secondary | Long-term outcome: neurodevelopmental impairment | Relation of ICV flow with Bayley mental and motor scales at 2 years of age, as rou-tinely performed by the COS - Centrum voor Ontwikkelingsstoornissen. | 3-5 years |
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