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

NCT06768203 | Completed

• 1 other identifier: EskisehirOU-UVC STUDY
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding Intolerance; Necrotising Enterocolitis Neonatal

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The splanchnic oxygenation (rSO2S)

  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

  first week of life (7 days)

Secondary Outcomes (1)

• The incidence of feeding intolerance and necrotizing enterocolitis.

  During hospital stay (maximum 3 months)

Study Arms (2)

The UVC (+) Study Group

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.

Other: umbilical vein catheterization

The UVC (-) Control Group

Infants who did not have a UVC but matched the Study Group regarding gestational age and birth weight constituted the UVC (-) Control Group.

Other: Control

Interventions

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

The UVC (+) Study Group

Control OTHER

No umbilical vein catheter was inserted in these infants.

The UVC (-) Control Group

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants whose gestational age is \<34 weeks, birth weight 1000-2000 grams.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Location

Related Publications (3)

• van der Heide M, Dotinga BM, Stewart RE, Kalteren WS, Hulscher JBF, Reijneveld SA, Bos AF, Kooi EMW. Regional splanchnic oxygen saturation for preterm infants in the first week after birth: reference values. Pediatr Res. 2021 Oct;90(4):882-887. doi: 10.1038/s41390-020-01323-3. Epub 2021 Jan 27.

  PMID: 33504960 RESULT

• Surmeli Onay O, Velipasaoglu M, Tutal M, Sarilar TD, Cakil Saglik A, Bilgin M, Aydemir O, Barsan Kaya T, Tanir HM, Tekin AN. The effect of drip versus intermittent feeding on splanchnic oxygenation in preterm infants with intrauterine growth restriction: a prospective randomized trial. Eur J Pediatr. 2023 Mar;182(3):1317-1328. doi: 10.1007/s00431-023-04810-x. Epub 2023 Jan 13.

  PMID: 36637540 RESULT

• Sulemanji M, Vakili K, Zurakowski D, Tworetzky W, Fishman SJ, Kim HB. Umbilical Venous Catheter Malposition Is Associated with Necrotizing Enterocolitis in Premature Infants. Neonatology. 2017;111(4):337-343. doi: 10.1159/000451022. Epub 2017 Jan 17.

  PMID: 28092913 RESULT

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Ozge Surmeli Onay

  Eskisehir Osmangazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 10, 2025
• Study Start: February 9, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)