Sonographic QUantification of Venous Circulation In the Preterm Brain

NCT04535375 | Completed

• 1 other identifier: SQUIB2020
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Prematurity; Extreme; Cerebral Circulatory Failure; Intraventricular Hemorrhage; Periventricular Leukomalacia

Keywords

Preterm infant, extremely preterm infant; Cerebral circulation; Venous Flow; Internal Cerebral Vein; Neurodevelopmental outcome; Intraventricular Hemorrhage; Periventricular Leukomalacia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Short-term outcome: cerebral complications in the neonatal phase

  2-3 years

• Long-term outcome: neurodevelopmental impairment

  3-5 years

Study Arms (2)

Preterm infants < 28 weeks gestational age

OTHER

For infants born before 28 0/7 weeks, standard of care consists of brain ultrasound performed on admission, day 1, day 2, day 3, day 7, and then weekly until discharge.

Diagnostic Test: Doppler Ultrasound of venous cerebral circulation

Preterm infants born between 28 0/7 and 31 6/7 weeks

OTHER

For infants born between 28 0/7 and 31 6/7 weeks, brain ultrasound is performed on admission, once between day 1 and 3, once between day 7 and 10, and then 2-weekly until discharge or transfer.

Diagnostic Test: Doppler Ultrasound of venous cerebral circulation

Interventions

Doppler Ultrasound of venous cerebral circulation DIAGNOSTIC_TEST

No additional ultrasound examinations, specifically for the purpose of this study, will be performed. Instead, with each routine ultrasound examination, additional images on top of the routine frames will be collected. Those images will document the velocity and flow in the internal cerebral veins bilaterally using the standard Color Doppler tech-nique. Taking these additional images will prolong the time of ultrasound examination only minimally (with a few minutes).

Preterm infants < 28 weeks gestational age; Preterm infants born between 28 0/7 and 31 6/7 weeks

Eligibility Criteria

• Age: Up to 3 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

Related Publications (21)

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  PMID: 305471 BACKGROUND

• Osborn DA, Evans N, Kluckow M. Hemodynamic and antecedent risk factors of early and late periventricular/intraventricular hemorrhage in premature infants. Pediatrics. 2003 Jul;112(1 Pt 1):33-9. doi: 10.1542/peds.112.1.33.

  PMID: 12837865 BACKGROUND

• Kluckow M, Evans N. Low superior vena cava flow and intraventricular haemorrhage in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F188-94. doi: 10.1136/fn.82.3.f188.

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  PMID: 10794783 BACKGROUND

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MeSH Terms

Conditions

Premature Birth; Leukomalacia, Periventricular

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalomalacia; Vascular Diseases; Cardiovascular Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Paul Govaert, MD PhD

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Extra ultrasound images will be exported anonymized and analyses offline by two investigators independently
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, Clinical professor

Model Details: All stable preterm infants born before a gestational age of 32 weeks are eligible for inclusion. Since standard ultrasound protocol is different for preterm infants born below or after 28 weeks, two subgroups will be created.

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 2, 2020
• Study Start: January 1, 2021
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)