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

Completed

• Conditions: Preterm Intraventricular Hemorrhage

• Registration Number: NCT05050032
• Lead Sponsor: Marwa Mohamed Farag

Brief Summary

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.

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:

1. First phase: Enrollment and selection phase.

2. Second phase: Monitoring and Evaluation phase.

3. Third phase: Statistical analysis of the data

Study Timeline

• Study Start: 2020-05-10
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Primary Completion: 2021-09-20
• Study First Posted: 2021-09-20
• Study Completion: 2021-10-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Superior vena cava (SVC) flow	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
Intraventricular hemorrhage (IVH) assessment	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
Anterior cerebral artery (ACA) flow velocity assessment	Day 1	Transcranial Doppler (TCD) ultrasonography was used to assess the anterior cerebral artery flow velocity

Trial Locations

Locations (1)

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.; 🇪🇬 Alexandria, Egypt