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Completed

NCT Number: NCT06768203

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

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.

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Key information

Conditions

Feeding Intolerance Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Necrotising Enterocolitis Neonatal

Age range

1 day–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Eskisehir Osmangazi University

Eskişehir, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

umbilical vein catheterization

Other

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

Control

Other

No umbilical vein catheter was inserted in these infants.

Primary outcomes

  1. The splanchnic oxygenation (rSO2S)

    Time frame: 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 outcomes

  1. The incidence of feeding intolerance and necrotizing enterocolitis.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

The Effect of Umbilical Vein Catheterization on Splanchnic Oxygenation

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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