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Preterm Intraventricular HemorrhageNCT05050032

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

An observational study of Preterm Intraventricular Hemorrhage, run by Marwa Mohamed Farag at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 to 1 day
Conditions the study is for
Preterm Intraventricular Hemorrhage
How many people
50 participants
Where
1 siteEgypt
Study dates
10 May 2020to 1 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 to 1 day
  • All sexes
  • Child

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

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

    Alexandria, 21131

Other trials in Egypt

About this study

Official title: 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.

Read the 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 1

  2. 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

    Measured: Day 1

  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.
    • 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

    Measured: Day 3

  4. 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

    Measured: Day 7

  5. Anterior cerebral artery (ACA) flow velocity assessment

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

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2021
  2. Study start10 May 2020
  3. Primary completion20 Sep 2021
  4. Study completion1 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05050032
Sponsor's protocol ID
0106381
Status last verified
Jun 2022
First submitted
10 Sep 2021
Last updated
15 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No

Publications

  • 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.

    PubMed 10794783

  • 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.

    PubMed 305471

  • 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.

    PubMed 36171508

Questions about this trial

What is this clinical trial studying?

An observational study of Preterm Intraventricular Hemorrhage, run by Marwa Mohamed Farag at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Superior vena cava (SVC) flow (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05050032, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.

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