Clinical trial NCT06768203: The Effect of Umbilical Vein Catheterization on Splanchnic Oxygenation in Preterm Infants
Official title: The Effect of Umbilical Vein Catheterization on Splanchnic Oxygenation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Feeding Intolerance
Necrotising Enterocolitis Neonatal
Keywords: umbilical venous catheter
splanchnic oxygenation
near-infrared spectroscopy
small for gestational age
feeding intolerance
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 48
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants whose gestational age is \<34 weeks, birth weight 1000-2000 grams.

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..

Eligibility criteria: 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)

Primary outcomes:
measure: The splanchnic oxygenation (rSO2S)
timeFrame: first week of life (7 days)
Secondary outcomes:
measure: The incidence of feeding intolerance and necrotizing enterocolitis.
timeFrame: During hospital stay (maximum 3 months)
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
Study officials:
affiliation: Eskisehir Osmangazi University
name: Ozge Surmeli Onay
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.