Effectiveness of Peripheral Intravenous Line Securement With Splint in Neonates

May 14, 2026 updated by: Muhammad Aamir Latif

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Dr. Ruth KM Pfau Civil Hospital/Dow University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Neonates
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group-A
Neonates were supported with a splint for PIVC securement.
Procedure: Splint
Neonates were supported with a splint for PIVC securement.
Active Comparator: Group-B
Neonates were not supported with a splint for PIVC securement.
Procedure: Neonates were not supported with a splint
Neonates were not supported with a splint for PIVC securement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammad Aamir Latif

Investigators

  • Principal Investigator: Zainab Khalid, Dr. Ruth KM Pfau Civil Hospital/Karachi, Dow University of Health Sciences, Karachi
  • Study Director: Muhammad Rafique, FCPS, Dr. Ruth KM Pfau Civil Hospital, Karachi/Dow University of Health Sciences, Karachi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Actual)

March 31, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

May 9, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dr. Zainab-Karachi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared on a reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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