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Completed

NCT Number: NCT05050032

The Relationship Between Superior Vena Cava Flow and Intraventricular Hemorrhage in Preterm Infants

The aim of the study was to evaluate the relationship between superior vena cava (SVC) flow measurements within the first 24 hours of life and development of intraventricular hemorrhage in preterm born infants.

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Key information

Conditions

Preterm Intraventricular Hemorrhage

Age range

1 day–1 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Alexandria, 21131, Egypt

About this study

A prospective, observational cohort study was carried out on newborns that fulfill the eligibility criteria and delivered at the Alexandria University Maternity Hospital (AUMH).

The Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital with total admissions of approximately 2100 newborn per year of which approximately more than 50% are admitted due to prematurity and its complications.

The study was carried out in 3 phases:

  • First phase: Enrollment and selection phase.
  • Second phase: Monitoring and Evaluation phase.
  • Third phase: Statistical analysis of the data

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newborns with very low birth weight (≤1500 g) or ≤ 32 weeks gestation who were admitted to neonatal intensive care unit in the first day of life.

Exclusion criteria

  • Newborns (more than 32 weeks of gestation
  • Newborns with birth weight more than 1500 g.
  • Newborns with congenital heart diseases excluding (patent ductus arteriosus and patent foramen ovale)
  • Newborns with major congenital malformations.
  • Newborns with birth trauma especially basal skull/temporal bone fractures that require hospitalization

Treatment and study plan

Primary outcomes

  1. Superior vena cava (SVC) flow

    Time frame: Day 1

    This was measured using echocardiography. SVC diameter will be visualized from a high parasternal long axis view. The maximum and minimum internal diameters will be then measured off-line from a frozen two-dimensional image showing the vessel walls at the point where SVC starts to open up into the right atrium. Mean of the maximum and minimum diameter used for the flow calculation.

    • SVC flow velocity will be visualized from a low subcostal view and the pulsed Doppler recording will be made at the junction of the SVC and the right atrium. Velocity time integral (VTI) will be calculated from the Doppler velocity tracings and averaged over 5 consecutive cardiac cycles.
    • SVC flow will be calculated using the method described by Kluckow and Evans:

    SVC flow (ml/kg/min) = {VTI (cm/beat) × 3.14 × (mean SVC diameter2/4) × heart rate (beat/min) }/body weight in kg

  2. Intraventricular hemorrhage (IVH) assessment

    Time frame: Day 1

    Cranial ultrasound will be performed after the echocardiography:

    • Machine: model GE Vivid iq premium.
    • Probe: GE 8C-RS probe with a frequency range of 3.5 - 10 MHz.
    • Cranial ultrasound will be done and any IVH will be noted and classified according to Papile grading:

    Grade I: Hemorrhage limited to germinal matrix Grade II: Blood noted within the ventricular system but not distending it Grade III: Blood in the ventricles with distension of the ventricles Grade IV: Intraventricular hemorrhage with parenchymal extension

  3. Intraventricular hemorrhage (IVH) assessment

    Time frame: Day 3

    Cranial ultrasound will be performed after the echocardiography:

    • Machine: model GE Vivid iq premium.
    • Probe: GE 8C-RS probe with a frequency range of 3.5 - 10 MHz.
    • IVH will be noted and classified according to Papile grading:

    Grade I: Hemorrhage limited to germinal matrix Grade II: Blood noted within the ventricular system but not distending it Grade III: Blood in the ventricles with distension of the ventricles Grade IV: Intraventricular hemorrhage with parenchymal extension

  4. Intraventricular hemorrhage (IVH) assessment

    Time frame: Day 7

    Cranial ultrasound will be performed after the echocardiography:

    • Machine: model GE Vivid iq premium.
    • Probe: GE 8C-RS probe with a frequency range of 3.5 - 10 MHz.
    • Cranial ultrasound will be done and any IVH will be noted and classified according to Papile grading:

    Grade I: Hemorrhage limited to germinal matrix Grade II: Blood noted within the ventricular system but not distending it Grade III: Blood in the ventricles with distension of the ventricles Grade IV: Intraventricular hemorrhage with parenchymal extension

  5. Anterior cerebral artery (ACA) flow velocity assessment

    Time frame: Day 1

    Transcranial Doppler (TCD) ultrasonography was used to assess the anterior cerebral artery flow velocity

Sponsors and collaborators

Lead sponsor

Marwa Mohamed Farag

Other

Registry information

Official study title

Study to Assess the Relationship Between Superior Vena Cava Flow and Intraventricular Hemorrhage in Preterm Infants

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 20, 2021
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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