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New care bundle slashes IV complications in kids at ER

NCT ID NCT07649499

Prevention Sponsor: Istanbul University - Cerrahpasa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a care bundle—a set of steps including nurse training, hand washing, and special cleaning solutions—to prevent IV-related problems like swelling and vein inflammation in children. Researchers compared 200 kids in the emergency department who either got the care bundle or standard care. The goal was to see if the bundle reduces these complications and improves first-attempt success.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

200 people

The number who actually took part.

Started

Jan 2024

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

28 days to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Children admitted to the Pediatric Emergency Department First-time peripheral intravenous catheter (PIVC) insertion Ages between 28 days to 18 years At least 6 hours of observation after catheter insertion Fluid administration in the observation area (e.g., 5% dextrose + 0.45% NaCl + 5/10 cc potassium) Written informed consent obtained from parents/legal guardians Children willing to participate in the study Exclusion Criteria: Children with skin problems (e.g., epidermolysis bullosa) Children allergic to products used in the care bundle Children who have undergone procedures that could cause catheter displacement or infiltration (e.g., lumbar puncture) Children with chronic vascular issues (e.g., vasculitis, hematologic disorders, congenital vascular anomalies) Children transferred to intensive care or another department after PIVC insertion Children with clinical conditions that prevent standard care bundle application (e.g., extreme agitation, inability to immobilize extremities)

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Conditions

The condition(s) this trial relates to.

phlebitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infiltration Intravenous Intravenous catheters Pediatrics Phlebitis

Contacts and locations

Locations

  • Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

    Istanbul, Turkey (Türkiye)

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