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CompletedNCT07589010Updated May 15, 2026

Effectiveness of Peripheral Intravenous Line Securement With Splint in Neonates

An interventional study of Splint and Neonates were not supported with a splint in Peripheral Intravenous Line, sponsored by Muhammad Aamir Latif. Completed at 1 site in Pakistan. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Muhammad Aamir Latif · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Oct 2025, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
1 Day to 28 Days
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Peripheral Intravenous Line
03

In context

Lead sponsor

Muhammad Aamir Latif is the lead sponsor of 56 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
192 participants (actual)

Study arms

  • Experimental
    Group-A

    Neonates were supported with a splint for PIVC securement.

    Procedure: Splint

  • Active comparator
    Group-B

    Neonates were not supported with a splint for PIVC securement.

    Procedure: Neonates were not supported with a splint

Interventions

  • ProcedureSplint

    Neonates were supported with a splint for PIVC securement.

  • ProcedureNeonates were not supported with a splint

    Neonates were not supported with a splint for PIVC securement.

06

What researchers measure

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.

    Time frame: One week

07

Study locations

1 site
  • Dr. Ruth KM Pfau Civil Hospital/Dow University of Health Sciences
    Karachi, Sindh 74200, Pakistan
08

References and documents

Individual participant data

Plan to share: No — Data can be shared on a reasonable request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07589010
Lead sponsor
Muhammad Aamir Latif
Responsible party
Muhammad Aamir Latif (Research Consultant, RESnTEC, Institute of Research) — Sponsor-investigator
First posted
May 15, 2026
Start date
Oct 1, 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026
Last update
May 15, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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