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CompletedNCT06768203Updated Jan 10, 2025

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

An observational study in Feeding Intolerance and Necrotising Enterocolitis Neonatal, sponsored by Eskisehir Osmangazi University. Completed at 1 site in Turkey. Open to participants aged 1 Day to 3 Months. Per ClinicalTrials.gov, last updated 2025-01-10.

Sponsored by Eskisehir Osmangazi University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
48
Ages
1 Day to 3 Months
Sex
All
01

Study 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.

Read the 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..

02

Conditions studied

  • Feeding Intolerance
  • Necrotising Enterocolitis Neonatal

Keywords

  • umbilical venous catheter
  • splanchnic oxygenation
  • near-infrared spectroscopy
  • small for gestational age
  • feeding intolerance
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Who can participate

Ages eligible
1 Day to 3 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
48 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • Otherumbilical vein catheterization

    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.

05

What researchers measure

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

    Time frame: first week of life (7 days)

Secondary outcomes

  1. The incidence of feeding intolerance and necrotizing enterocolitis.

    The secondary outcomes involve evaluating the relationship between UVC presence and the incidence of feeding intolerance and necrotizing enterocolitis.

    Time frame: During hospital stay (maximum 3 months)

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Study locations

1 site
  • Eskisehir Osmangazi University
    Eskisehir, Turkey
07

References and documents

Publications

  • 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. PubMed 33504960 ↗
  • 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. PubMed 36637540 ↗
  • 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. PubMed 28092913 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 8, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT06768203
Lead sponsor
Eskisehir Osmangazi University
Responsible party
Ozge Surmeli Onay (Professor Doctor, Eskisehir Osmangazi University) — Principal investigator
First posted
Jan 10, 2025
Start date
Feb 9, 2023
Primary completion
Feb 1, 2024
Completion
Apr 1, 2024
Last update
Jan 10, 2025

Study contacts

Ozge Surmeli Onay
study director · Eskisehir Osmangazi University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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