Neonatal Peripheral Intravenous CannulationNCT06615063
Limb Splinting for Intravenous Cannulae in Neonates and Its Effects on Life Span of Intravenous Cannulae
A study testing Hasi's Splint in people with Neonatal Peripheral Intravenous Cannulation and Limb Splinting, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial summary
The goal of this randomized controlled trial is to assess the effectiveness of limb splinting in increasing the lifespan of intravenous (IV) cannulae in neonates. The study involves neonatal patients requiring peripheral IV cannulation. Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Neonatal Peripheral Intravenous Cannulation, Limb Splinting, Intravenous Cannula Lifespan
- What is being tested?
- Hasi's Splint
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Dec 2022to 10 Oct 2023
- 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 1 hour to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All neonates with intravenous cannulae
Who cannot join
- All neonates in neonatal ICU
- All neonates with central venous line in place
- All neonates that are on ventilatory support
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Pediatric Surgery,Holy Family Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: Limb Splinting for Intravenous Cannulae in Neonates and Its Effects on Life Span of Intravenous Cannulae; A Randomised Controlled Trial.
The goal of this randomized controlled trial is to assess the effectiveness of limb splinting in increasing the lifespan of intravenous (IV) cannulae in neonates. The study involves neonatal patients requiring peripheral IV cannulation. The main questions it aims to answer are:
Does limb splinting increase the lifespan of IV cannulae compared to non-splinting? What are the effects of splinting on the incidence of complications like extravasation, occlusion, and leakage? Researchers will compare neonates with IV cannulae in splinted limbs to those with IV cannulae in non-splinted limbs to see if splinting extends the cannula's lifespan and reduces complications.
Read more
Participants will:
Undergo peripheral IV cannulation with and without limb splinting. Have the lifespan of their IV cannulae monitored and recorded until removal due to various complications or routine changes.
Read the detailed description
This randomized controlled trial aims to investigate the impact of limb splinting on the lifespan of intravenous (IV) cannulae in neonates. The study is motivated by the need to enhance the efficacy and safety of peripheral IV cannulation in neonates, who frequently require intravenous access for the administration of medications and fluids during hospitalization. Peripheral IV cannulation, although common, is associated with a limited dwell time and various complications, including extravasation, occlusion, and leakage, which can lead to multiple cannulations and increased discomfort for neonates.
The study is designed to compare the lifespan of IV cannulae in neonates who have their limbs splinted with those who do not. The primary focus is on whether splinting the limb can effectively increase the dwell time of the IV cannula, thereby reducing the frequency of cannulation and associated complications. The trial involves 246 neonates, randomly assigned to either the splint or non-splint group, with an equal number of participants in each group.
Neonates included in the study will undergo standard peripheral IV cannulation procedures, with all cannulae being inserted by experienced medical staff under controlled conditions. In the splint group, the limb with the IV cannula will be immobilized using a splint, while in the non-splint group, the limb will not be splinted. The time from cannula insertion to removal will be meticulously recorded for each neonate, along with any complications that arise, such as extravasation, accidental dislodgment, infiltration, phlebitis, leakage, or occlusion.
Data will be collected using a self-designed questionnaire, ensuring that the information is only accessible to the primary investigator to maintain data integrity and confidentiality. The study will employ rigorous statistical analysis, including two-sample t-tests to compare the mean dwell times between the splinted and non-splinted groups, and Spearman's rank analysis to explore correlations between various parameters.
The outcomes of this trial are expected to provide valuable insights into the effectiveness of limb splinting as a technique for increasing the lifespan of IV cannulae in neonates. The findings could potentially influence clinical practices by identifying a simple yet effective method to enhance the safety and comfort of neonatal patients requiring IV therapy.
- Conditions
- Neonatal Peripheral Intravenous Cannulation, Limb Splinting, Intravenous Cannula Lifespan, Extravasation, Extravasation Injury
- Being tested
- Hasi's Splint
- Keywords
- Neonatal Care, Intravenous Cannulation, Splinting, Neonatal Surgery, Pediatric Surgery, Extravasation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hasi's SplintOther
A splint made up of cotton and gauze piece rolled over a hard cardboard piece and covered by adhesive tape was applied to the limb immediately after fixing the cannula, as per the standardised method, to prevent movement at the underlying joint. Dimensions of the splints used were standardised as length extending two and a half inches on either side of the joint and width equal to the width of the limb just proximal to the joint.
| Study group | Role | What they receive |
|---|---|---|
| Splint Group | Experimental | These neonates receive peripheral intravenous cannulation with limb splinting. Receives: Other: Hasi's Splint |
| Non-Splint Group | No intervention | These neonates receive peripheral intravenous cannulation without limb splinting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
lifespan (dwell time) of the intravenous (IV) cannulae.
The study aims to compare the mean dwell time of IV cannulae between the splinted and non-splinted groups to determine if limb splinting has a significant effect on extending the duration for which the cannula remains functional before removal.
Measured: from 0 to 48 hours
Secondary outcomes (1)
Incidence of Complications
Various complications related to IV cannulation are assessed, including:
Extravasation Accidental Dislodgment Infiltration Phlebitis Leakage Occlusion
Measured: from 0 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start10 Dec 2022
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Neonatal Peripheral Intravenous CannulationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The interventional study model of the above article is a Parallel Assignment model. In this study, neonates are randomly assigned to one of two groups: one group receives the intervention (limb splinting) while the other group does not (non-splinted). The outcomes (e.g., lifespan of the IV cannula, incidence of complications) are then compared between these two parallel groups to determine the effectiveness of the intervention.
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnain Aslam, Rawalpindi Medical College
- Investigators
- Ali Raza Chaudhry, MBBS, MS, Study director, Rawalpindi Medical CollegeMudassar Fiaz Gondal, MBBS, MS, Study chair, Rawalpindi Medical Collegehasnain Aslam, MBBS, Principal investigator, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615063
- Sponsor's protocol ID
- RMU-RRF-SUR-007-23
- Status last verified
- Sep 2024
- First submitted
- 14 Aug 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barker DP, Rutter N. Exposure to invasive procedures in neonatal intensive care unit admissions. Arch Dis Child Fetal Neonatal Ed. 1995 Jan;72(1):F47-8. doi: 10.1136/fn.72.1.f47.
PubMed 7743285Bakr AF. Intravenous lines-related sepsis in newborn babies admitted to NICU in a developing country. J Trop Pediatr. 2003 Oct;49(5):295-7. doi: 10.1093/tropej/49.5.295.
PubMed 14604163Gupta 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 12923741Mewahegn AA, Tadesse B, GebreEyesus FA, Tarekegn TT, Amlak BT, Emeria MS, Temere BC, Terefe TF, Zewudie BT, Geletie HA, Mengist ST. Lifespan and Associated Factors of Peripheral Intravenous Cannula Among Hospitalized Children in Public Hospitals of the Gurage Zone, Ethiopia, 2021. Pediatric Health Med Ther. 2022 Mar 25;13:81-93. doi: 10.2147/PHMT.S351759. eCollection 2022.
PubMed 35368745Franck LS, Hummel D, Connell K, Quinn D, Montgomery J. The safety and efficacy of peripheral intravenous catheters in ill neonates. Neonatal Netw. 2001 Aug;20(5):33-8. doi: 10.1891/0730-0832.20.5.33.
PubMed 12144220Birhane E, Kidanu K, Kassa M, Gerezgiher D, Tsegay L, Weldu B, Kidane G, Gerensea H. Lifespan and associated factors of peripheral intravenous Cannula among infants admitted in public hospitals of Mekelle City, Tigray, Ethiopia, 2016. BMC Nurs. 2017 Jun 15;16:33. doi: 10.1186/s12912-017-0227-1. eCollection 2017.
PubMed 28638278Dalal SS, Chawla D, Singh J, Agarwal RK, Deorari AK, Paul VK. Limb splinting for intravenous cannulae in neonates: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2009 Nov;94(6):F394-6. doi: 10.1136/adc.2008.147595. Epub 2009 May 12.
PubMed 19439433Morris W, Heong Tay M. Strategies for preventing peripheral intravenous cannula infection. Br J Nurs. 2008 Oct 23-Nov 12;17(19):S14-21. doi: 10.12968/bjon.2008.17.Sup8.31470.
PubMed 18974681Johnson RV, Donn SM. Life span of intravenous cannulas in a neonatal intensive care unit. Am J Dis Child. 1988 Sep;142(9):968-71. doi: 10.1001/archpedi.1988.02150090066024.
PubMed 3414629Shenoy S, Karunakar BP. Factors influencing the peripheral venous catheter survival in critically ill children in a pediatric intensive care unit. Indian J Pediatr. 2014 Dec;81(12):1293-6. doi: 10.1007/s12098-014-1430-7. Epub 2014 May 6.
PubMed 24796410Serane V T, Rajasekaran R, Vijayadevagaran V, Kothendaraman B. Peripheral intravenous cannulae in neonates: To splint or not? J Vasc Access. 2022 May;23(3):398-402. doi: 10.1177/1129729821996926. Epub 2021 Feb 23.
PubMed 33619983
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limb Splinting for Intravenous Cannulae in Neonates and Its Effects on Life Span of Intravenous Cannulae; A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT06615063
- Acronym / sponsor ID
- RMU-RRF-SUR-007-23
- Conditions
- Neonatal Peripheral Intravenous Cannulation, Limb Splinting, Intravenous Cannula Lifespan, Extravasation, Extravasation Injury
- Keywords
- Neonatal Care, Intravenous Cannulation, Splinting, Neonatal Surgery, Pediatric Surgery, Extravasation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 26 Sep 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.
The goal of this randomized controlled trial is to assess the effectiveness of limb splinting in increasing the lifespan of intravenous (IV) cannulae in neonates. The study involves neonatal patients requiring peripheral IV cannulation. The main questions it aims to answer are:
Does limb splinting increase the lifespan of IV cannulae compared to non-splinting? What are the effects of splinting on the incidence of complications like extravasation, occlusion, and leakage? Researchers will compare neonates with IV cannulae in splinted limbs to those with IV cannulae in non-splinted limbs to see if splinting extends the cannula's lifespan and reduces complications.
Participants will:
Undergo peripheral IV cannulation with and without limb splinting. Have the lifespan of their IV cannulae monitored and recorded until removal due to various complications or routine changes.
Detailed description
This randomized controlled trial aims to investigate the impact of limb splinting on the lifespan of intravenous (IV) cannulae in neonates. The study is motivated by the need to enhance the efficacy and safety of peripheral IV cannulation in neonates, who frequently require intravenous access for the administration of medications and fluids during hospitalization. Peripheral IV cannulation, although common, is associated with a limited dwell time and various complications, including extravasation, occlusion, and leakage, which can lead to multiple cannulations and increased discomfort for neonates.
The study is designed to compare the lifespan of IV cannulae in neonates who have their limbs splinted with those who do not. The primary focus is on whether splinting the limb can effectively increase the dwell time of the IV cannula, thereby reducing the frequency of cannulation and associated complications. The trial involves 246 neonates, randomly assigned to either the splint or non-splint group, with an equal number of participants in each group.
Neonates included in the study will undergo standard peripheral IV cannulation procedures, with all cannulae being inserted by experienced medical staff under controlled conditions. In the splint group, the limb with the IV cannula will be immobilized using a splint, while in the non-splint group, the limb will not be splinted. The time from cannula insertion to removal will be meticulously recorded for each neonate, along with any complications that arise, such as extravasation, accidental dislodgment, infiltration, phlebitis, leakage, or occlusion.
Data will be collected using a self-designed questionnaire, ensuring that the information is only accessible to the primary investigator to maintain data integrity and confidentiality. The study will employ rigorous statistical analysis, including two-sample t-tests to compare the mean dwell times between the splinted and non-splinted groups, and Spearman's rank analysis to explore correlations between various parameters.
The outcomes of this trial are expected to provide valuable insights into the effectiveness of limb splinting as a technique for increasing the lifespan of IV cannulae in neonates. The findings could potentially influence clinical practices by identifying a simple yet effective method to enhance the safety and comfort of neonatal patients requiring IV therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The interventional study model of the above article is a Parallel Assignment model. In this study, neonates are randomly assigned to one of two groups: one group receives the intervention (limb splinting) while the other group does not (non-splinted). The outcomes (e.g., lifespan of the IV cannula, incidence of complications) are then compared between these two parallel groups to determine the effectiveness of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Splint Group | Experimental | Other: Hasi's SplintThese neonates receive peripheral intravenous cannulation with limb splinting. |
| Non-Splint Group | No intervention | –These neonates receive peripheral intravenous cannulation without limb splinting. |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All neonates with intravenous cannulae
Key exclusion criteria (3 listed)
- All neonates in neonatal ICU
- All neonates with central venous line in place
- All neonates that are on ventilatory support
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 |
|---|---|---|
| Hasi's SplintA splint made up of cotton and gauze piece rolled over a hard cardboard piece and covered by adhesive tape was applied to the limb immediately after fixing the cannula, as per the standardised method, to prevent movement at the underlying joint. Dimensions of the splints used were standardised as length extending two and a half inches on either side of the joint and width equal to the width of the limb just proximal to the joint. | Other | Splint Group |
Primary outcome
lifespan (dwell time) of the intravenous (IV) cannulae.
Time frame: from 0 to 48 hours
The study aims to compare the mean dwell time of IV cannulae between the splinted and non-splinted groups to determine if limb splinting has a significant effect on extending the duration for which the cannula remains functional before removal.
1 secondary outcome
Incidence of Complications
Time frame: from 0 to 48 hours
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 26 Sep 2024.
- Results publication: PubMed 7743285Barker DP, Rutter N. Exposure to invasive procedures in neonatal intensive care unit admissions. Arch Dis Child Fetal Neonatal Ed. 1995 Jan;72(1):F47-8. doi: 10.1136/fn.72.1.f47.
- Results publication: PubMed 14604163Bakr AF. Intravenous lines-related sepsis in newborn babies admitted to NICU in a developing country. J Trop Pediatr. 2003 Oct;49(5):295-7. doi: 10.1093/tropej/49.5.295.
- Results publication: 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.
- Results publication: PubMed 35368745Mewahegn AA, Tadesse B, GebreEyesus FA, Tarekegn TT, Amlak BT, Emeria MS, Temere BC, Terefe TF, Zewudie BT, Geletie HA, Mengist ST. Lifespan and Associated Factors of Peripheral Intravenous Cannula Among Hospitalized Children in Public Hospitals of the Gurage Zone, Ethiopia, 2021. Pediatric Health Med Ther. 2022 Mar 25;13:81-93. doi: 10.2147/PHMT.S351759. eCollection 2022.
- Results publication: PubMed 12144220Franck LS, Hummel D, Connell K, Quinn D, Montgomery J. The safety and efficacy of peripheral intravenous catheters in ill neonates. Neonatal Netw. 2001 Aug;20(5):33-8. doi: 10.1891/0730-0832.20.5.33.
- Results publication: PubMed 28638278Birhane E, Kidanu K, Kassa M, Gerezgiher D, Tsegay L, Weldu B, Kidane G, Gerensea H. Lifespan and associated factors of peripheral intravenous Cannula among infants admitted in public hospitals of Mekelle City, Tigray, Ethiopia, 2016. BMC Nurs. 2017 Jun 15;16:33. doi: 10.1186/s12912-017-0227-1. eCollection 2017.
- Results publication: PubMed 19439433Dalal SS, Chawla D, Singh J, Agarwal RK, Deorari AK, Paul VK. Limb splinting for intravenous cannulae in neonates: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2009 Nov;94(6):F394-6. doi: 10.1136/adc.2008.147595. Epub 2009 May 12.
- Results publication: PubMed 18974681Morris W, Heong Tay M. Strategies for preventing peripheral intravenous cannula infection. Br J Nurs. 2008 Oct 23-Nov 12;17(19):S14-21. doi: 10.12968/bjon.2008.17.Sup8.31470.
- Results publication: PubMed 3414629Johnson RV, Donn SM. Life span of intravenous cannulas in a neonatal intensive care unit. Am J Dis Child. 1988 Sep;142(9):968-71. doi: 10.1001/archpedi.1988.02150090066024.
- Results publication: PubMed 24796410Shenoy S, Karunakar BP. Factors influencing the peripheral venous catheter survival in critically ill children in a pediatric intensive care unit. Indian J Pediatr. 2014 Dec;81(12):1293-6. doi: 10.1007/s12098-014-1430-7. Epub 2014 May 6.
- Results publication: PubMed 33619983Serane V T, Rajasekaran R, Vijayadevagaran V, Kothendaraman B. Peripheral intravenous cannulae in neonates: To splint or not? J Vasc Access. 2022 May;23(3):398-402. doi: 10.1177/1129729821996926. Epub 2021 Feb 23.
- 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.
Ali Raza Chaudhry, MBBS, MS study director
Rawalpindi Medical College
Mudassar Fiaz Gondal, MBBS, MS study chair
Rawalpindi Medical College
hasnain Aslam, MBBS principal investigator
Rawalpindi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hasi's Splint in people with Neonatal Peripheral Intravenous Cannulation and Limb Splinting, run by Rawalpindi Medical College at 1 site in Pakistan.
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 3 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 26 Sep 2024. 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 Pakistan. 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?
lifespan (dwell time) of the intravenous (IV) cannulae. (time frame: from 0 to 48 hours). 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 NCT06615063, which also lists 11 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 26 Sep 2024.