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The Effect of Umbilical Vein Catheterization on Splanchnic Oxygenation in Preterm Infants

The Effect of Umbilical Vein Catheterization on Splanchnic Oxygenation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06768203
Enrollment
48
Registered
2025-01-10
Start date
2023-02-09
Completion date
2024-04-01
Last updated
2025-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Intolerance, Necrotising Enterocolitis Neonatal

Keywords

umbilical venous catheter, splanchnic oxygenation, near-infrared spectroscopy, small for gestational age, feeding intolerance

Brief summary

Objectives: This study aimed to assess the impact of umbilical vein catheter (UVC) placement on splanchnic oxygenation in preterm infants. Methods: In our single-center, prospective, observational cohort study, near-infrared spectroscopy probes were placed to monitor regional splanchnic oxygen saturation (rSO2S) and calculate fractional tissue oxygen extraction (FOE) in preterm infants (GA \< 34 weeks, BW 1000-2000 g) for one week post-stabilization. Gestational age-matched UVC (+) and (-) Groups were clinically and physiologically compared, before and after UVC placement/removal.

Detailed description

The purpose of this study was to evaluate how the insertion of an umbilical vein catheter (UVC) affected the splanchnic oxygenation of preterm newborns..

Interventions

In our NICU, UVC placement is a sterile bedside procedure carried out by pediatric residents, neonatology fellows, and neonatology specialists, using polyurethane, single-lumen catheters sized according to the infant's weight: 3.5 Fr for those under 1500 g and 5 Fr for those over 1500 g. Catheter placement is performed using the Modified Shukla-Ferrara Formula

OTHERControl

No umbilical vein catheter was inserted in these infants.

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 3 Months
Healthy volunteers
No

Inclusion criteria

* Parents agreed to participate in the study * Infants born in our hospital, who were followed up in the NICU, with a gestational age of \<34 weeks and a birth weight of 1000-2000 grams * Infants who indicated UVC placement, and for whom NIRS measurements were taken both before and after UVC placement were included in the UVC (+) Study Group * Infants who did not have a UVC but matched the Study Group regarding gestational age and birth weight constituted the UVC (-) Control Group

Exclusion criteria

* Infants who died during the first week of life * Transferred to another hospital * Chromosomal anomalies * Major congenital anomalies affecting splanchnic bed monitoring (such as congenital heart disease, abdominal wall defects, or congenital diaphragmatic hernia) * Inherited metabolic disorders * Hydrops fetalis * TORCH infections * Multiple organ failure * Spontaneous intestinal perforation * Lesions in the area where the NIRS sensor was placed * If UVC was removed for any reason before 24 hours * Severe anemia or polycythemia (Infants with a birth hemoglobin (Hb) level of 10 g/dl or below were considered severe anemic, and those with a Hb level of 22 g/dl or above were considered polycythemic)

Design outcomes

Primary

MeasureTime frameDescription
The splanchnic oxygenation (rSO2S)first week of life (7 days)The primary outcomes included comparing continuously recorded rSO2S and FOE values during the first week of life between the UVC (+) and UVC (-) groups, assessing rSO2S and FOE measurements within the UVC (+) Group before and after UVC placement and removal, and determining the impact of UVC on splanchnic oxygenation

Secondary

MeasureTime frameDescription
The incidence of feeding intolerance and necrotizing enterocolitis.During hospital stay (maximum 3 months)The secondary outcomes involve evaluating the relationship between UVC presence and the incidence of feeding intolerance and necrotizing enterocolitis.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026