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

Completed

• Conditions: Feeding Intolerance; Necrotising Enterocolitis Neonatal

• Registration Number: NCT06768203
• Lead Sponsor: Eskisehir Osmangazi University

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..

Study Timeline

• Study Start: 2023-02-09
• Primary Completion: 2024-02-01
• Study Completion: 2024-04-01
• Study First Submitted: 2024-12-23
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Eskisehir Osmangazi University; 🇹🇷 Eskisehir, Turkey