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Clinical Trials/NCT07589010
NCT07589010CompletedNot Applicable

Effectiveness of Peripheral Intravenous Line Securement With Splint in Neonates Admitted to the Neonatal Intensive Care Unit.

Muhammad Aamir Latif1 site in 1 country192 target enrollmentStarted: October 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
192
Locations
1
Primary Endpoint
Dwell time

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
1 Day to 28 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Any gender
  • Admitted to the NICU and required PIVC insertion

Exclusion Criteria

  • 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

Arms & Interventions

Group-A

Experimental

Neonates were supported with a splint for PIVC securement.

Intervention: Splint (Procedure)

Group-B

Active Comparator

Neonates were not supported with a splint for PIVC securement.

Intervention: Neonates were not supported with a splint (Procedure)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Muhammad Aamir Latif
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Muhammad Aamir Latif

Research Consultant

RESnTEC, Institute of Research

Study Sites (1)

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