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
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.
The purpose of this study was to evaluate how the insertion of an umbilical vein catheter (UVC) affected the splanchnic oxygenation of preterm newborns..
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's enrollment of 48 is below the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Eskisehir Osmangazi University is the lead sponsor of 153 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Preterm infants whose gestational age is \<34 weeks, birth weight 1000-2000 grams.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
No umbilical vein catheter was inserted in these infants.
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)
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)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2023 to primary completion in Feb 2024, 11 months.
Of 39 observational studies under Enterocolitis, Necrotizing, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 115. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eskisehir Osmangazi University →