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

NCT05050032 | Completed

• 1 other identifier: 0106381
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Intraventricular Hemorrhage

Outcome Measures

Primary Outcomes (5)

• Superior vena cava (SVC) flow

  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

  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

  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

  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

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

  Day 1

Eligibility Criteria

• Age: 1 Day - 1 Day
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Marwa Mohamed Farag: lead

Study Sites (1)

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

Alexandria, 21131, Egypt

Location

Related Publications (3)

• Kluckow M, Evans N. Superior vena cava flow in newborn infants: a novel marker of systemic blood flow. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F182-7. doi: 10.1136/fn.82.3.f182.

  PMID: 10794783 BACKGROUND

• Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978 Apr;92(4):529-34. doi: 10.1016/s0022-3476(78)80282-0.

  PMID: 305471 BACKGROUND

• Farag MM, Gouda MH, Almohsen AMA, Khalifa MA. Intraventricular hemorrhage prediction in premature neonates in the era of hemodynamics monitoring: a prospective cohort study. Eur J Pediatr. 2022 Dec;181(12):4067-4077. doi: 10.1007/s00431-022-04630-5. Epub 2022 Sep 28.

  PMID: 36171508 DERIVED

Study Officials

• Mohamed AM Khalifa, MBBCh

  Faculty of Medicine, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Mohamed H Gouda, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY DIRECTOR

• Ali M Abd Almohsen, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY DIRECTOR

• Marwa M Farag, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer in Pediatrics, Faculty of Medicine

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 20, 2021
• Study Start: May 10, 2020
• Primary Completion: September 20, 2021
• Study Completion: October 1, 2021
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

EG (1)