Peripheral Intravenous LineNCT07589010
Effectiveness of Peripheral Intravenous Line Securement With Splint in Neonates
A study testing Splint and Neonates were not supported with a splint in people with Peripheral Intravenous Line, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Splints are often used in neonatal intensive care units (NICUs) to immobilize the limb and stabilize the catheter, theoretically reducing complications by minimizing movement at the catheter site. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Peripheral Intravenous Line
- What is being tested?
- Splint and Neonates were not supported with a splint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2025to 31 Mar 2026
- 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 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates
- Any gender
- Admitted to the NICU and required PIVC insertion
Who cannot join
- Skin conditions like fragile skin syndromes, dermatitis, or local infections that may worsen with splint and adhesive use
- Congenital limb deformities like clubfoot, polydactyly, joint contractures that impede proper splint application
- Severe limb edema
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dr. Ruth KM Pfau Civil Hospital/Dow University of Health Sciences
Karachi, Sindh, 74200
About this study
Official title: Effectiveness of Peripheral Intravenous Line Securement With Splint in Neonates Admitted to the Neonatal Intensive Care Unit.
Splints are often used in neonatal intensive care units (NICUs) to immobilize the limb and stabilize the catheter, theoretically reducing complications by minimizing movement at the catheter site. Unfortunately, not much local data exist on the effectiveness of splints for peripheral intravenous line securement (PIVC). This study aimed to compare the dwell time of PIVCs with and without splints in neonates admitted to the NICU.
Read the detailed description
The expected outcomes, which included optimized PIVC management protocols that could lower the frequency of catheter replacements, thereby reducing neonatal distress and the risk of infection. Establishing clear best practices may improve overall care quality, enhance workflow efficiency for NICU staff, and ultimately lead to better health outcomes. The findings could support the development of standardized guidelines for PIVC securement, with implications not only for local but also for global neonatal care settings.
- Conditions
- Peripheral Intravenous Line
- Being tested
- Splint, Neonates were not supported with a splint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SplintProcedure or surgery
Neonates were supported with a splint for PIVC securement.
Neonates were not supported with a splintProcedure or surgery
Neonates were not supported with a splint for PIVC securement.
| Study group | Role | What they receive |
|---|---|---|
| Group-A | Experimental | Neonates were supported with a splint for PIVC securement. Receives: Procedure: Splint |
| Group-B | Active comparator | Neonates were not supported with a splint for PIVC securement. Receives: Procedure: Neonates were not supported with a splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dwell time
The dwell time of PIVCs with and without splints was compared, calculated from PIVC insertion to the completion of the therapy.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Oct 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Intravenous LineStudies 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
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Zainab Khalid, Principal investigator, Dr. Ruth KM Pfau Civil Hospital/Karachi, Dow University of Health Sciences, KarachiMuhammad Rafique, FCPS, Study director, Dr. Ruth KM Pfau Civil Hospital, Karachi/Dow University of Health Sciences, Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589010
- Sponsor's protocol ID
- Dr. Zainab-Karachi
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Peripheral Intravenous Line Securement With Splint in Neonates Admitted to the Neonatal Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT07589010
- Acronym / sponsor ID
- Dr. Zainab-Karachi
- Conditions
- Peripheral Intravenous Line
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 15 May 2026 (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.
Splints are often used in neonatal intensive care units (NICUs) to immobilize the limb and stabilize the catheter, theoretically reducing complications by minimizing movement at the catheter site. Unfortunately, not much local data exist on the effectiveness of splints for peripheral intravenous line securement (PIVC). This study aimed to compare the dwell time of PIVCs with and without splints in neonates admitted to the NICU.
Detailed description
The expected outcomes, which included optimized PIVC management protocols that could lower the frequency of catheter replacements, thereby reducing neonatal distress and the risk of infection. Establishing clear best practices may improve overall care quality, enhance workflow efficiency for NICU staff, and ultimately lead to better health outcomes. The findings could support the development of standardized guidelines for PIVC securement, with implications not only for local but also for global neonatal care settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A | Experimental | Procedure: SplintNeonates were supported with a splint for PIVC securement. |
| Group-B | Active comparator | Procedure: Neonates were not supported with a splintNeonates were not supported with a splint for PIVC securement. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates
- Any gender
- Admitted to the NICU and required PIVC insertion
Key exclusion criteria (3 listed)
- Skin conditions like fragile skin syndromes, dermatitis, or local infections that may worsen with splint and adhesive use
- Congenital limb deformities like clubfoot, polydactyly, joint contractures that impede proper splint application
- Severe limb edema
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 |
|---|---|---|
| SplintNeonates were supported with a splint for PIVC securement. | Procedure or surgery | Group-A |
| Neonates were not supported with a splintNeonates were not supported with a splint for PIVC securement. | Procedure or surgery | Group-B |
Primary outcome
Dwell time
Time frame: One week
The dwell time of PIVCs with and without splints was compared, calculated from PIVC insertion to the completion of the therapy.
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 15 May 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Related trials for Peripheral Intravenous Line
Recruiting
Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children.
Pain Management
Active, not recruitingObservational study
A New Landmark-formula for Cephalic Vein in Children
Venipuncture, Ultrasound
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.
Zainab Khalid principal investigator
Dr. Ruth KM Pfau Civil Hospital/Karachi, Dow University of Health Sciences, Karachi
Muhammad Rafique, FCPS study director
Dr. Ruth KM Pfau Civil Hospital, Karachi/Dow University of Health Sciences, Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splint and Neonates were not supported with a splint in people with Peripheral Intravenous Line, run by Muhammad Aamir Latif 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 3 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 15 May 2026. 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?
Dwell time (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2026.