Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05729321
Other study ID # 4880
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date September 1, 2023

Study information

Verified date February 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Epicutaneo-caval catheters (ECCs) are widely used in neonatal intensive care units (NICUs). They are small catheters inserted via superficial veins of the limbs or scalp using direct vein visualization The pathogenic microorganisms colonized inside catheters can easily form a bacterial biofilm and eventually spread with blood flow which causes bloodstream infection. Many authors have studied the antibiotic-lock therapy (ALT) in which a high-dose antibiotic solution is dripped and maintained in the catheter cavity for a certain period and can dissolve the biofilm formed on the wall to reduce the colonization of the bacteria and kill the embedded bacteria.The aim of the study is to evaluate the patency of the Epicutaneo-caval catheter after its closure for 1 hour.


Recruitment information / eligibility

Status Recruiting
Enrollment 7
Est. completion date September 1, 2023
Est. primary completion date November 5, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: All the Epicutaneo-caval catheter that need to be removed electively will be included in the study - Exclusion Criteria: All the Epicutaneo-caval catheters removed not electively but for infectious or mechanical complications will be excluded from the study. -

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
neutrox
Each ECC, after discontinuing the Parental Nutrition (NP) infusion, will be flushed with 0.3 ml saline. Subsequently, Saline will be infused at a rate of 2 ml/h for 10 minutes. The ECC will then be closed for 1 hour. At the end of the hour the ECC will be once again flushed with 0.3 ml Saline and infused with SF at the rate of 2 cc/h for 10 minutes. The difference in pressure of the two infusions, before and after catheter closure, will be evaluated.

Locations

Country Name City State
Italy Fondazione Policlinico Gemelli IRCSS Roma Itsly
Italy FPGemelliIRCCS Rome

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Barone G, Pittiruti M, Biasucci DG, Elisei D, Iacobone E, La Greca A, Zito Marinosci G, D'Andrea V. Neo-ECHOTIP: A structured protocol for ultrasound-based tip navigation and tip location during placement of central venous access devices in neonates. J Vasc Access. 2022 Sep;23(5):679-688. doi: 10.1177/11297298211007703. Epub 2021 Apr 5. — View Citation

Barone G, Pittiruti M. Epicutaneo-caval catheters in neonates: New insights and new suggestions from the recent literature. J Vasc Access. 2020 Nov;21(6):805-809. doi: 10.1177/1129729819891546. Epub 2019 Dec 5. — View Citation

Dumichen MJ, Seeger K, Lode HN, Kuhl JS, Ebell W, Degenhardt P, Singer M, Geffers C, Querfeld U. Randomized controlled trial of taurolidine citrate versus heparin as catheter lock solution in paediatric patients with haematological malignancies. J Hosp Infect. 2012 Apr;80(4):304-9. doi: 10.1016/j.jhin.2012.01.003. Epub 2012 Feb 18. — View Citation

Jain A, Deshpande P, Shah P. Peripherally inserted central catheter tip position and risk of associated complications in neonates. J Perinatol. 2013 Apr;33(4):307-12. doi: 10.1038/jp.2012.112. Epub 2012 Sep 6. — View Citation

Viale P, Pagani L, Petrosillo N, Signorini L, Colombini P, Macri G, Cristini F, Gattuso G, Carosi G; Italian Hospital and HIV Infection Group. Antibiotic lock-technique for the treatment of catheter-related bloodstream infections. J Chemother. 2003 Apr;15(2):152-6. doi: 10.1179/joc.2003.15.2.152. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pressure level mmHg The aim of the study is to evaluate the patency of the Epicutaneo-caval catheter after its closure for 1 hour. 1 hours
See also
  Status Clinical Trial Phase
Recruiting NCT06105333 - Fidgety Movements of Preterm Neonates Included in COSGOD III
Completed NCT05509621 - The Effect of Positions on Physiological Parameters of Preterm Neonates Receiving Mechanical Ventilation N/A
Enrolling by invitation NCT06116747 - The SUPPORTED Study - First-time Fathers of Preterm Infants. N/A
Active, not recruiting NCT01443195 - Iron Metabolism in Small Pre Term Newborns N/A
Withdrawn NCT05053269 - Body Weight Growth After Birth and Bronchopulmonary Dysplasia
Not yet recruiting NCT06118801 - The Effect of Probiotics Added to the Mother's Diet on Preterm Babies N/A
Completed NCT05453734 - The Effect of Progressive Muscle Relaxation Exercises N/A
Recruiting NCT05230199 - Sensory Optimization of the Hospital Environment N/A
Completed NCT06204146 - The Effect of Massage on Growth And Stress And Stress ,Department of Nursing, N/A
Recruiting NCT05687500 - Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP) Phase 2
Completed NCT05830955 - The Effect of Lullaby and Breastmilk Smell on Preterm Newborns N/A
Active, not recruiting NCT06246032 - Impact of Modified Feeding Protocol on Neonatal Outcomes N/A
Not yet recruiting NCT05331235 - Blood Transfusions in Preterm Infants
Completed NCT05359809 - Peripheral Intravenous Central Catheter Intervention in Preterm Infants N/A
Not yet recruiting NCT05434364 - Comparison Three Methods on Endotracheal Aspiration in Preterm Infants N/A
Completed NCT05805254 - Neurofunctional Study of Preterm Infants' Brain Activity
Completed NCT01776281 - Effects of Kangaroo Mother Care Among Low Birth Weight (LBW) and Preterm Infants Phase 2
Completed NCT05978674 - The Effect of Rocking Bed on Preterm Newborns N/A
Completed NCT05261503 - Investigation of the Effectiveness of Environmental Enrichment-Based Intervention in Preterm Infants N/A
Recruiting NCT05293353 - Neokare Safety and Tolerability Assessment in Neonates With GI Problems