Effectiveness of Peripheral Intravenous Line Securement With Splint in Neonates

NCT07589010 | Completed

• 1 other identifier: Dr. Zainab-Karachi
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Intravenous Line

Outcome Measures

Primary Outcomes (1)

• Dwell time

  The dwell time of PIVCs with and without splints was compared, calculated from PIVC insertion to the completion of the therapy.

  One week

Study Arms (2)

Group-A

EXPERIMENTAL

Neonates were supported with a splint for PIVC securement.

Procedure: Splint

Group-B

ACTIVE COMPARATOR

Neonates were not supported with a splint for PIVC securement.

Procedure: Neonates were not supported with a splint

Interventions

Splint PROCEDURE

Neonates were supported with a splint for PIVC securement.

Group-A

Neonates were not supported with a splint PROCEDURE

Neonates were not supported with a splint for PIVC securement.

Group-B

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Dr. Ruth KM Pfau Civil Hospital/Dow University of Health Sciences

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Interventions

Splints

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Zainab Khalid

  Dr. Ruth KM Pfau Civil Hospital/Karachi, Dow University of Health Sciences, Karachi

  PRINCIPAL INVESTIGATOR

• Muhammad Rafique, FCPS

  Dr. Ruth KM Pfau Civil Hospital, Karachi/Dow University of Health Sciences, Karachi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 15, 2026
• Study Start: October 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)