The Effect of Umbilical Vein Catheterization on Splanchnic Oxygenation in Preterm Infants (NCT06768203) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Umbilical Vein Catheterization on Splanchnic Oxygenation in Preterm Infants
Turkey (Türkiye)48 participantsStarted 2023-02-09
Plain-language 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.
Who can participate
Age range
1 Day – 3 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.