Preterm Clinical Trial
— LOOSENOfficial title:
Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates: a "LOOSEN" Pilot Study
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 |
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.
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. - |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Gemelli IRCSS | Roma | Itsly |
Italy | FPGemelliIRCCS | Rome |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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
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 |
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
|