Preterm InfantLittleReedNCT03597711
Comparing the Effectiveness of a Safety Intravenous Cannula With a Standard Intravenous Cannula in Neonates
A study testing IVcannulation in people with Preterm Infant, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A smaller caliber of intravenous cannulae decreases the number of thrombi and phlebitis and improves the duration of peripheral access. It also reduces the incidence of extravasation. 26G cannulae are easier to insert and reduce the number of attempts for cannulation. Read more about this study
- Who is it for?
- Ages 23 to 32 weeks
- Conditions the study is for
- Preterm Infant
- What is being tested?
- IVcannulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2018to 1 Jul 2019
- Phase
- Interventional
- 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 23 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates < 32 Gestation
- < 1.5 kg weight
- Admitted to NICU,St Mary's Hospital Manchester.
Who cannot join
- .Neonates with severe skin conditions such as Epidermolysis Bullosa.
- Infants of > 32 weeks Gestation
- > 1.5 kg in birth weight. .Known difficult venous access (clinical decision). .Expected transfer to different neonatal or paediatric unit within 24hr of intended cannulation.
- .Patients considered for reorientation of care or palliative care. .Infants previously recruited to the study who had a total of 3 episodes of randomization.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Neonatal Intensive Care Unit, St Mary's Hospital
Manchester, M13 9WL
About this study
Official title: Comparison of 24G Versus 26G Peripheral Intravenous Safety Cannula and a 24G Non Safety Cannula in a Population of Neonates <32 Weeks Gestation and <1.5Kg Birthweight
A smaller caliber of intravenous cannulae decreases the number of thrombi and phlebitis and improves the duration of peripheral access. It also reduces the incidence of extravasation. 26G cannulae are easier to insert and reduce the number of attempts for cannulation. Safety cannulae are equivalent in terms of durability and ease of insertion, additionally providing a reduction in needle stick injury amongst healthcare professionals and patients.
The goal of this study is to reduce the number of peripheral line insertions and resulting complications in neonates.
Read more
The Investigators propose to compare 24G safety and 26G safety cannulae with non-safety 24G cannulae in infants < 32 weeks Gestation and < 1.5 kg weight in terms of length of stay of cannula, ease of insertion and rates of complications such as thrombosis, phlebitis and extravasation.
The Investigators will also evaluate the frequency of needle stick injury to staff and patients in the course of the study.
Read the detailed description
Peripheral venous cannulation is a common procedure on neonatal NICU. Insertion of peripheral cannulae in neonates is a painful and stressful procedure (5) and it is therefore desirable to minimize the number of procedures by increasing the survival time of each cannula. The incidence of phlebitis is variously described as 20 - 80% (2). Failure of venous access is often due to thrombi, phlebitis and extravasation. Mechanical phlebitis can be avoided by using the smallest gauge cannula capable of delivering the prescribed drug. (1) Mechanical phlebitis occurs where there is movement of a foreign object (cannula) within a vein causing friction and subsequent inflammation(3). Success rates for cannulation depend on a range of factors including the clinician's experience, gauge of cannula and infants weight as well as the condition of veins. Median survival of 24G Teflon intravenous cannulae was described as 40 hours in one study (4). There are few studies on the appropriate sizing of intravenous cannulae in children.
Flow rates for intravenous devise vary greatly depending on the manufacturer. Flow rates for 24G cannulae are 13 - 29 ml/min. The 26G cannulae achieve flow rates of 13 -19 ml/min which is adequate for use on NICU. The most commonly used devise on NICU SMH are 24G cannulae with a flow rates between13ml/min and 25 ml/min depending on manufacturer.
In this study the proposed non-safety 24 G cannula achieves a flow rate of 25 ml/min whereas the safety 24G and 26 G cannula achieve 22ml/ min and 15ml/min respectively.
Within the EU safety devices are mandatory since 2010 (6). Needle stick injuries during venepuncture pose a risk for healthcare professionals and other staff due to the transmission of blood borne pathogens such as Hepatitis B, Hepatitis C and HIV. This has cost implications for the NHS.
Safety cannulae in both 24 and 26 G have been trialed on the investigator's NICU in 2017 and are felt to be an important addition providing both safe and reliable cannulation. The design of the safety cannula is very similar to cannulae already used on the unit and handling does not require change in practice.
Due to the winged design of both safety and non-safety cannulae fixation of the line post insertion can be standardized.
- Conditions
- Preterm Infant
- Being tested
- IVcannulation
- Keywords
- Peripheral Intravenous cannulation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVcannulationDevice
Also called 24G non-safety cannula,26G safety cannula,24G safety cannula
Peripheral venous cannulation is a common procedure on neonatal NICU, especially in preterm infants
| Study group | Role | What they receive |
|---|---|---|
| IVCannulation 24G non-safety cannula | Active comparator | Peripheral Intravenous cannulation using 24G non-safety cannula Receives: Device: IVcannulation |
| IVCannulation 26G safety cannula | Active comparator | Peripheral Intravenous cannulation using 26G safety cannula Receives: Device: IVcannulation |
| IVCannulation 24G safety cannula | Active comparator | Peripheral Intravenous cannulation using 24G safety cannula Receives: Device: IVcannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay of cannula
How long the cannula continues to work
Measured: Maximum of a week
Secondary outcomes (2)
ease of insertion
How easy or difficult staff find the cannula to insert
Measured: Maximum of a week
rates of complications
thrombosis, phlebitis and extravasation
Measured: Average of a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start20 Jun 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once consent is obtained, patients will be randomized to either 24G non-safety cannula, 24G safety or 26G safety cannula. Each patient can enter the study a maximum of three times providing 90 episodes of cannulation.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anna Pawleletz, Principal investigator, Manchester University Foundation Trust, Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597711
- Sponsor's protocol ID
- R04615
- Acronym
- LittleReed
- Status last verified
- Mar 2020
- First submitted
- 14 Jun 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Panadero A, Iohom G, Taj J, Mackay N, Shorten G. A dedicated intravenous cannula for postoperative use effect on incidence and severity of phlebitis. Anaesthesia. 2002 Sep;57(9):921-5. doi: 10.1046/j.1365-2044.2002.02786.x.
PubMed 12190760Stokowski G, Steele D, Wilson D. The use of ultrasound to improve practice and reduce complication rates in peripherally inserted central catheter insertions: final report of investigation. J Infus Nurs. 2009 May-Jun;32(3):145-55. doi: 10.1097/NAN.0b013e3181a1a98f.
PubMed 19444022Gupta P, Rai R, Basu S, Faridi MM. Life span of peripheral intravenous cannula in a neonatal intensive care unit of a developing country. J Pediatr Nurs. 2003 Aug;18(4):287-92. doi: 10.1016/s0882-5963(03)00052-6.
PubMed 12923741
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 24G Versus 26G Peripheral Intravenous Safety Cannula and a 24G Non Safety Cannula in a Population of Neonates <32 Weeks Gestation and <1.5Kg Birthweight
- ClinicalTrials.gov ID
- NCT03597711
- Acronym / sponsor ID
- LittleReed / R04615
- Conditions
- Preterm Infant
- Keywords
- Peripheral Intravenous cannulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 24 Jul 2018 (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.
A smaller caliber of intravenous cannulae decreases the number of thrombi and phlebitis and improves the duration of peripheral access. It also reduces the incidence of extravasation. 26G cannulae are easier to insert and reduce the number of attempts for cannulation. Safety cannulae are equivalent in terms of durability and ease of insertion, additionally providing a reduction in needle stick injury amongst healthcare professionals and patients.
The goal of this study is to reduce the number of peripheral line insertions and resulting complications in neonates.
The Investigators propose to compare 24G safety and 26G safety cannulae with non-safety 24G cannulae in infants < 32 weeks Gestation and < 1.5 kg weight in terms of length of stay of cannula, ease of insertion and rates of complications such as thrombosis, phlebitis and extravasation.
The Investigators will also evaluate the frequency of needle stick injury to staff and patients in the course of the study.
Detailed description
Peripheral venous cannulation is a common procedure on neonatal NICU. Insertion of peripheral cannulae in neonates is a painful and stressful procedure (5) and it is therefore desirable to minimize the number of procedures by increasing the survival time of each cannula. The incidence of phlebitis is variously described as 20 - 80% (2). Failure of venous access is often due to thrombi, phlebitis and extravasation. Mechanical phlebitis can be avoided by using the smallest gauge cannula capable of delivering the prescribed drug. (1) Mechanical phlebitis occurs where there is movement of a foreign object (cannula) within a vein causing friction and subsequent inflammation(3). Success rates for cannulation depend on a range of factors including the clinician's experience, gauge of cannula and infants weight as well as the condition of veins. Median survival of 24G Teflon intravenous cannulae was described as 40 hours in one study (4). There are few studies on the appropriate sizing of intravenous cannulae in children.
Flow rates for intravenous devise vary greatly depending on the manufacturer. Flow rates for 24G cannulae are 13 - 29 ml/min. The 26G cannulae achieve flow rates of 13 -19 ml/min which is adequate for use on NICU. The most commonly used devise on NICU SMH are 24G cannulae with a flow rates between13ml/min and 25 ml/min depending on manufacturer.
In this study the proposed non-safety 24 G cannula achieves a flow rate of 25 ml/min whereas the safety 24G and 26 G cannula achieve 22ml/ min and 15ml/min respectively.
Within the EU safety devices are mandatory since 2010 (6). Needle stick injuries during venepuncture pose a risk for healthcare professionals and other staff due to the transmission of blood borne pathogens such as Hepatitis B, Hepatitis C and HIV. This has cost implications for the NHS.
Safety cannulae in both 24 and 26 G have been trialed on the investigator's NICU in 2017 and are felt to be an important addition providing both safe and reliable cannulation. The design of the safety cannula is very similar to cannulae already used on the unit and handling does not require change in practice.
Due to the winged design of both safety and non-safety cannulae fixation of the line post insertion can be standardized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Once consent is obtained, patients will be randomized to either 24G non-safety cannula, 24G safety or 26G safety cannula. Each patient can enter the study a maximum of three times providing 90 episodes of cannulation.
| Arm | Type | Receives |
|---|---|---|
| IVCannulation 24G non-safety cannula | Active comparator | Device: IVcannulationPeripheral Intravenous cannulation using 24G non-safety cannula |
| IVCannulation 26G safety cannula | Active comparator | Device: IVcannulationPeripheral Intravenous cannulation using 26G safety cannula |
| IVCannulation 24G safety cannula | Active comparator | Device: IVcannulationPeripheral Intravenous cannulation using 24G safety cannula |
Who may qualify
- Ages
- 23 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates < 32 Gestation
- < 1.5 kg weight
- Admitted to NICU,St Mary's Hospital Manchester.
Key exclusion criteria (4 listed)
- .Neonates with severe skin conditions such as Epidermolysis Bullosa.
- Infants of > 32 weeks Gestation
- > 1.5 kg in birth weight. .Known difficult venous access (clinical decision). .Expected transfer to different neonatal or paediatric unit within 24hr of intended cannulation.
- .Patients considered for reorientation of care or palliative care. .Infants previously recruited to the study who had a total of 3 episodes of randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVcannulationAlso: 24G non-safety cannula,26G safety cannula,24G safety cannulaPeripheral venous cannulation is a common procedure on neonatal NICU, especially in preterm infants | Device | IVCannulation 24G non-safety cannula, IVCannulation 24G safety cannula, IVCannulation 26G safety cannula |
Primary outcome
length of stay of cannula
Time frame: Maximum of a week
How long the cannula continues to work
2 secondary outcomes
ease of insertion
Time frame: Maximum of a week
rates of complications
Time frame: Average of a week
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 17 Mar 2020.
- Background: PubMed 12190760Panadero A, Iohom G, Taj J, Mackay N, Shorten G. A dedicated intravenous cannula for postoperative use effect on incidence and severity of phlebitis. Anaesthesia. 2002 Sep;57(9):921-5. doi: 10.1046/j.1365-2044.2002.02786.x.
- Background: PubMed 19444022Stokowski G, Steele D, Wilson D. The use of ultrasound to improve practice and reduce complication rates in peripherally inserted central catheter insertions: final report of investigation. J Infus Nurs. 2009 May-Jun;32(3):145-55. doi: 10.1097/NAN.0b013e3181a1a98f.
- Background: PubMed 12923741Gupta P, Rai R, Basu S, Faridi MM. Life span of peripheral intravenous cannula in a neonatal intensive care unit of a developing country. J Pediatr Nurs. 2003 Aug;18(4):287-92. doi: 10.1016/s0882-5963(03)00052-6.
- Individual participant dataSharing planned: No
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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.
Anna Pawleletz principal investigator
Manchester University Foundation Trust, Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVcannulation in people with Preterm Infant, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 4 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 17 Mar 2020. 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 United Kingdom. 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?
length of stay of cannula (time frame: Maximum of a week). 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 NCT03597711, which also lists 3 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 17 Mar 2020.