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

NCT ID: NCT05050032

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-10

Study Completion Date

2021-10-01

Brief Summary

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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

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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

Conditions

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Preterm Intraventricular Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marwa Mohamed Farag

OTHER

Sponsor Role lead

Responsible Party

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Marwa Mohamed Farag

Lecturer in Pediatrics, Faculty of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed AM Khalifa, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Alexandria University, Egypt

Mohamed H Gouda, PhD

Role: STUDY_DIRECTOR

Faculty of Medicine, Alexandria University, Egypt

Ali M Abd Almohsen, PhD

Role: STUDY_DIRECTOR

Faculty of Medicine, Alexandria University, Egypt

Marwa M Farag, PhD

Role: STUDY_CHAIR

Faculty of Medicine, Alexandria University, Egypt

Locations

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

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 10794783 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 305471 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36171508 (View on PubMed)

Other Identifiers

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0106381

Identifier Type: -

Identifier Source: org_study_id

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