Clinical trial NCT05050032: The Relationship Between Superior Vena Cava Flow and Intraventricular Hemorrhage in Preterm Infants
Official title: Study to Assess the Relationship Between Superior Vena Cava Flow and Intraventricular Hemorrhage in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Intraventricular Hemorrhage
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Superior vena cava (SVC) flow
timeFrame: Day 1
measure: Intraventricular hemorrhage (IVH) assessment
timeFrame: Day 1
measure: Intraventricular hemorrhage (IVH) assessment
timeFrame: Day 3
measure: Intraventricular hemorrhage (IVH) assessment
timeFrame: Day 7
measure: Anterior cerebral artery (ACA) flow velocity assessment
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Study officials:
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Mohamed AM Khalifa, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Mohamed H Gouda, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Ali M Abd Almohsen, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Marwa M Farag, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.