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

June 13, 2022 updated by: Marwa Mohamed Farag

Study to Assess 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.

Study Overview

Status

Completed

Conditions

Preterm Intraventricular Hemorrhage

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Egypt
- - Alexandria, Egypt, 21131
    - Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 day (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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 where evaluation of the relationship between superior vena cava (SVC) flow measurements within the first 24 hours of life and development of intraventricular hemorrhage were assessed.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1
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	Day 1
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	Day 3
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	Day 7
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	Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marwa Mohamed Farag

Investigators

Principal Investigator: Mohamed AM Khalifa, MBBCh, Faculty of Medicine, Alexandria University, Egypt
Study Director: Mohamed H Gouda, PhD, Faculty of Medicine, Alexandria University, Egypt
Study Director: Ali M Abd Almohsen, PhD, Faculty of Medicine, Alexandria University, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2020

Primary Completion (ACTUAL)

September 20, 2021

Study Completion (ACTUAL)

October 1, 2021

Study Registration Dates

First Submitted

September 10, 2021

First Submitted That Met QC Criteria