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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-09

Study Completion Date

2024-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Umbilical Cord Milking in Non-Vigorous Infants

NCT03631940

Birth Asphyxia

COMPLETED NA

Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants

NCT01255189

pOSitional Changes of Premature Infants

COMPLETED PHASE4

The Effect of Position Given to Preterms After Feeding on Gastric Residual Volume, Abdominal Oxygenation and Fractional Oxygen Extraction

NCT05888090

Gastric Residual Volume Abdominal Oxygenation Fractional Oxygen Extraction +1 more

COMPLETED NA

The Effect of Positions on Physiological Parameters of Preterm Neonates Receiving Mechanical Ventilation

NCT05509621

Preterm Nursing Caries

COMPLETED NA

Cerebral Oxygenation in Preterm Neonates with Respiratory Support During Skin-to-skin Care on the First Day After Birth

NCT04865302

Preterm Birth Ventilator Lung; Newborn

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study was to evaluate how the insertion of an umbilical vein catheter (UVC) affected the splanchnic oxygenation of preterm newborns..

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Feeding Intolerance Necrotising Enterocolitis Neonatal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

umbilical vein catheterization

Intervention Type 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 (-) 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.

Control

Intervention Type OTHER

No umbilical vein catheter was inserted in these infants.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

umbilical 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

Intervention Type OTHER

Control

No umbilical vein catheter was inserted in these infants.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No