Migration of Implant or Internal DeviceDISLOTIPNCT06438289
Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter.
An observational study of Migration of Implant or Internal Device, run by Federico II University at 1 site in Italy.
Trial summary
This is a non-pharmacological, non-profit, prospective, observational multicenter study. Primarily, the study aims to demonstrate the feasibility of ultrasound methodology to study the secondary malposition of epicutaneous-caval catheters (ECC) in neonates. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Migration of Implant or Internal Device
- How many people
- 217 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jan 2024to 15 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: neonates undergoing placement of 28G/1 Fr ECCs with a standardized securement system
Who may be able to join
- neonates undergoing placement of 28 G/1 Fr ECCs with a standardized securement system
Who cannot join
- neonates with major malformation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter: a Multicentric Study
This is a non-pharmacological, non-profit, prospective, observational multicenter study. Primarily, the study aims to demonstrate the feasibility of ultrasound methodology to study the secondary malposition of epicutaneous-caval catheters (ECC) in neonates.
After obtaining informed consent, the study involves performing ultrasound tip location on newborns who had an ECC placed. This will occur immediately after the placement and, if in a central position, subsequently at 60-120 minutes, 48-72 hours and 6-8 days post-placement. Data will be collected on various variables. Each Center will contribute at least 20 cases to the cohort and all data will be recorded in a database. The study is expected to last for 12 months
Read the detailed description
Epicutaneous-caval catheters (ECCs) are among the most common central venous catheters used in neonatology. It is known that they can experience malpositioning over time from the moment of placement, leading to complications. In all studies conducted so far, tip location has been performed using X-ray. Ultrasound would be the ideal method for serial, bedside and radiatIon-free evaluation of ECC tip location to intercept any migrations. The primary endpoint of the study is to demonstrate the feasibility of ultrasound method for the assessment of secondary ECC malposition. Secondary endpoints include validating the results of previous Investigators monocentric study on the feasibility of ultrasound tip location applied to ECC and establishing the incidence of secondary malpositioning and the optimal timing for reassessing tip position after ECC placement. All neonates undergoing placement of 28 Gauge/1 French ECCs with a standardized securement system are included in the study, while neonates with major malformation are excluded. The study includes: obtaining written informed consent; performing ultrasound tip location using a standardized protocol (high right parasternal, apical four-chamber, short-axis left parasternal and bicaval subcostal views); If the tip is in a central position, repeating ultrasound tip location (using the same protocol) at 60-120 minutes, 48-72 hours and 6-8 days post-placement; collecting variables including sex, site of ECC insertion, weight at placement and at each tip location, postmenstrual age at placement and at each tip location, days of life at placement and at each tip location, respiratory support at placement and at each tip location, feasibility of ultrasound tip location for each ECC and for each specified time, ultrasound tip location result for each ECC and for each specified time and any displacement relative to the time of placement, as wall as any reported complications associated with secondary malpositioning. All ultrasound will be performed with the newborn in a standardized position: limb adducted and elbow extended if the catheter is placed from the upper limb, limb adducted and knee extended if the catheter is placed from the lower limb, neutral position if the catheter is placed from the scalp. The records of the ultrasound exams at each time for the first five cases enrolled by each Center will be sent to the Coordinator Center for evaluation of protocol compliance. Using the exact binomial method and setting a margin of error of 4% for a 95% of confidence interval, the investigators calculated that the sample size should be 196. The collected data will be recorded anonymously in an Excel database. Continuous variables will be expressed as means with minimum and maximum ranges, while categorical variables will be expressed as frequencies with percentages. Each case will be identified with an alphanumeric code to ensure data confidentiality. The principal investigator is the only person able to link the code to the identity of the patient. Parents, relative or guardians of eligible patients will be provided with all explanations regarding the experimental protocol by the study staff before enrollment. Information will be provided and parents will be given up to 12 hours to give their consent. The principal investigator will be responsible for the overall monitoring of data and the safety of the study participants. No funding or additional costs beyond common current practice are anticipated.
- Conditions
- Migration of Implant or Internal Device
- Keywords
- tip location, ultrasound, epicutaneous-caval catheter, tip secondary migration, newborn, ECC
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cases in which ultrasound tip location is feasible to study ECC secondary malposition
percentage, from 0% to 100%
Measured: 8 days from the ECC placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start17 Jan 2024
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Migration of Implant or Internal DeviceStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Raimondi, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438289
- Sponsor's protocol ID
- Protocol 335
- Acronym
- DISLOTIP
- Status last verified
- Feb 2025
- First submitted
- 24 May 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Practice Guidelines for Central Venous Access 2020: An Updated Report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2020 Jan;132(1):8-43. doi: 10.1097/ALN.0000000000002864. No abstract available.
PubMed 31821240Barone 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.
PubMed 31804149Costello JM, Clapper TC, Wypij D. Minimizing complications associated with percutaneous central venous catheter placement in children: recent advances. Pediatr Crit Care Med. 2013 Mar;14(3):273-83. doi: 10.1097/PCC.0b013e318272009b.
PubMed 23392365de Jonge RC, Polderman KH, Gemke RJ. Central venous catheter use in the pediatric patient: mechanical and infectious complications. Pediatr Crit Care Med. 2005 May;6(3):329-39. doi: 10.1097/01.PCC.0000161074.94315.0A.
PubMed 15857534Acun C, Baker A, Brown LS, Iglesia KA, Sisman J. Peripherally inserted central cathether migration in neonates: Incidence, timing and risk factors. J Neonatal Perinatal Med. 2021;14(3):411-417. doi: 10.3233/NPM-200684.
PubMed 33459671Gupta R, Drendel AL, Hoffmann RG, Quijano CV, Uhing MR. Migration of Central Venous Catheters in Neonates: A Radiographic Assessment. Am J Perinatol. 2016 May;33(6):600-4. doi: 10.1055/s-0035-1570341. Epub 2016 Jan 5.
PubMed 26731179Srinivasan HB, Tjin-A-Tam A, Galang R, Hecht A, Srinivasan G. Migration patterns of peripherally inserted central venous catheters at 24 hours postinsertion in neonates. Am J Perinatol. 2013 Nov;30(10):871-4. doi: 10.1055/s-0033-1333672. Epub 2013 Feb 4.
PubMed 23381907Grasso F, Capasso A, Pacella D, Borgia F, Salome S, Capasso L, Raimondi F. Ultrasound Guided Catheter Tip Location in Neonates: A Prospective Cohort Study. J Pediatr. 2022 May;244:86-91.e2. doi: 10.1016/j.jpeds.2021.12.059. Epub 2021 Dec 28.
PubMed 34971654Grasso F, Capasso A, Dolce P, Ausanio G, Bernardo I, Poggi C, Dani C, Bonadies L, Baraldi E, Landi M, Tomasini B, Spagnuolo F, Carpentieri M, D'Andrea V, Vento G, Rodriguez-Perez C, Risso FM, Barone G, Ancora G, Ficial B, Biban P, Pittiruti M, Capasso L, Raimondi F. Ultrasound-guided tip location and detection of tip migration of neonatal peripherally inserted central catheters: a prospective, multicenter study (DISLOTIP study). Crit Care. 2025 Dec 20;29(1):532. doi: 10.1186/s13054-025-05800-1.
PubMed 41422244
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter: a Multicentric Study
- ClinicalTrials.gov ID
- NCT06438289
- Acronym / sponsor ID
- DISLOTIP / Protocol 335
- Conditions
- Migration of Implant or Internal Device
- Keywords
- tip location, ultrasound, epicutaneous-caval catheter, tip secondary migration, newborn, ECC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-pharmacological, non-profit, prospective, observational multicenter study. Primarily, the study aims to demonstrate the feasibility of ultrasound methodology to study the secondary malposition of epicutaneous-caval catheters (ECC) in neonates.
After obtaining informed consent, the study involves performing ultrasound tip location on newborns who had an ECC placed. This will occur immediately after the placement and, if in a central position, subsequently at 60-120 minutes, 48-72 hours and 6-8 days post-placement. Data will be collected on various variables. Each Center will contribute at least 20 cases to the cohort and all data will be recorded in a database. The study is expected to last for 12 months
Detailed description
Epicutaneous-caval catheters (ECCs) are among the most common central venous catheters used in neonatology. It is known that they can experience malpositioning over time from the moment of placement, leading to complications. In all studies conducted so far, tip location has been performed using X-ray. Ultrasound would be the ideal method for serial, bedside and radiatIon-free evaluation of ECC tip location to intercept any migrations. The primary endpoint of the study is to demonstrate the feasibility of ultrasound method for the assessment of secondary ECC malposition. Secondary endpoints include validating the results of previous Investigators monocentric study on the feasibility of ultrasound tip location applied to ECC and establishing the incidence of secondary malpositioning and the optimal timing for reassessing tip position after ECC placement. All neonates undergoing placement of 28 Gauge/1 French ECCs with a standardized securement system are included in the study, while neonates with major malformation are excluded. The study includes: obtaining written informed consent; performing ultrasound tip location using a standardized protocol (high right parasternal, apical four-chamber, short-axis left parasternal and bicaval subcostal views); If the tip is in a central position, repeating ultrasound tip location (using the same protocol) at 60-120 minutes, 48-72 hours and 6-8 days post-placement; collecting variables including sex, site of ECC insertion, weight at placement and at each tip location, postmenstrual age at placement and at each tip location, days of life at placement and at each tip location, respiratory support at placement and at each tip location, feasibility of ultrasound tip location for each ECC and for each specified time, ultrasound tip location result for each ECC and for each specified time and any displacement relative to the time of placement, as wall as any reported complications associated with secondary malpositioning. All ultrasound will be performed with the newborn in a standardized position: limb adducted and elbow extended if the catheter is placed from the upper limb, limb adducted and knee extended if the catheter is placed from the lower limb, neutral position if the catheter is placed from the scalp. The records of the ultrasound exams at each time for the first five cases enrolled by each Center will be sent to the Coordinator Center for evaluation of protocol compliance. Using the exact binomial method and setting a margin of error of 4% for a 95% of confidence interval, the investigators calculated that the sample size should be 196. The collected data will be recorded anonymously in an Excel database. Continuous variables will be expressed as means with minimum and maximum ranges, while categorical variables will be expressed as frequencies with percentages. Each case will be identified with an alphanumeric code to ensure data confidentiality. The principal investigator is the only person able to link the code to the identity of the patient. Parents, relative or guardians of eligible patients will be provided with all explanations regarding the experimental protocol by the study staff before enrollment. Information will be provided and parents will be given up to 12 hours to give their consent. The principal investigator will be responsible for the overall monitoring of data and the safety of the study participants. No funding or additional costs beyond common current practice are anticipated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- neonates undergoing placement of 28G/1 Fr ECCs with a standardized securement system
Key inclusion criteria (1 listed)
- neonates undergoing placement of 28 G/1 Fr ECCs with a standardized securement system
Key exclusion criteria (1 listed)
- neonates with major malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of cases in which ultrasound tip location is feasible to study ECC secondary malposition
Time frame: 8 days from the ECC placement
percentage, from 0% to 100%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Background: PubMed 31821240Practice Guidelines for Central Venous Access 2020: An Updated Report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2020 Jan;132(1):8-43. doi: 10.1097/ALN.0000000000002864. No abstract available.
- Background: PubMed 31804149Barone 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.
- Background: PubMed 23392365Costello JM, Clapper TC, Wypij D. Minimizing complications associated with percutaneous central venous catheter placement in children: recent advances. Pediatr Crit Care Med. 2013 Mar;14(3):273-83. doi: 10.1097/PCC.0b013e318272009b.
- Background: PubMed 15857534de Jonge RC, Polderman KH, Gemke RJ. Central venous catheter use in the pediatric patient: mechanical and infectious complications. Pediatr Crit Care Med. 2005 May;6(3):329-39. doi: 10.1097/01.PCC.0000161074.94315.0A.
- Background: PubMed 33459671Acun C, Baker A, Brown LS, Iglesia KA, Sisman J. Peripherally inserted central cathether migration in neonates: Incidence, timing and risk factors. J Neonatal Perinatal Med. 2021;14(3):411-417. doi: 10.3233/NPM-200684.
- Background: PubMed 26731179Gupta R, Drendel AL, Hoffmann RG, Quijano CV, Uhing MR. Migration of Central Venous Catheters in Neonates: A Radiographic Assessment. Am J Perinatol. 2016 May;33(6):600-4. doi: 10.1055/s-0035-1570341. Epub 2016 Jan 5.
- Background: PubMed 23381907Srinivasan HB, Tjin-A-Tam A, Galang R, Hecht A, Srinivasan G. Migration patterns of peripherally inserted central venous catheters at 24 hours postinsertion in neonates. Am J Perinatol. 2013 Nov;30(10):871-4. doi: 10.1055/s-0033-1333672. Epub 2013 Feb 4.
- Background: PubMed 34971654Grasso F, Capasso A, Pacella D, Borgia F, Salome S, Capasso L, Raimondi F. Ultrasound Guided Catheter Tip Location in Neonates: A Prospective Cohort Study. J Pediatr. 2022 May;244:86-91.e2. doi: 10.1016/j.jpeds.2021.12.059. Epub 2021 Dec 28.
- Derived from this study: PubMed 41422244Grasso F, Capasso A, Dolce P, Ausanio G, Bernardo I, Poggi C, Dani C, Bonadies L, Baraldi E, Landi M, Tomasini B, Spagnuolo F, Carpentieri M, D'Andrea V, Vento G, Rodriguez-Perez C, Risso FM, Barone G, Ancora G, Ficial B, Biban P, Pittiruti M, Capasso L, Raimondi F. Ultrasound-guided tip location and detection of tip migration of neonatal peripherally inserted central catheters: a prospective, multicenter study (DISLOTIP study). Crit Care. 2025 Dec 20;29(1):532. doi: 10.1186/s13054-025-05800-1.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migration of Implant or Internal Device, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of cases in which ultrasound tip location is feasible to study ECC secondary malposition (time frame: 8 days from the ECC placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06438289, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.