Clinical trial NCT06615063: Limb Splinting for Intravenous Cannulae in Neonates and Its Effects on Life Span of Intravenous Cannulae
Official title: Limb Splinting for Intravenous Cannulae in Neonates and Its Effects on Life Span of Intravenous Cannulae; A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Peripheral Intravenous Cannulation
Limb Splinting
Intravenous Cannula Lifespan
Extravasation
Extravasation Injury
Keywords: Neonatal Care
Intravenous Cannulation
Splinting
Neonatal Surgery
Pediatric Surgery
Extravasation
Lead sponsor: Rawalpindi Medical College
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 246
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The interventional study model of the above article is a Parallel Assignment model.

In this study, neonates are randomly assigned to one of two groups: one group receives the intervention (limb splinting) while the other group does not (non-splinted). The outcomes (e.g., lifespan of the IV cannula, incidence of complications) are then compared between these two parallel groups to determine the effectiveness of the intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized controlled trial is to assess the effectiveness of limb splinting in increasing the lifespan of intravenous (IV) cannulae in neonates. The study involves neonatal patients requiring peripheral IV cannulation. The main questions it aims to answer are:

Does limb splinting increase the lifespan of IV cannulae compared to non-splinting? What are the effects of splinting on the incidence of complications like extravasation, occlusion, and leakage? Researchers will compare neonates with IV cannulae in splinted limbs to those with IV cannulae in non-splinted limbs to see if splinting extends the cannula's lifespan and reduces complications.

Participants will:

Undergo peripheral IV cannulation with and without limb splinting. Have the lifespan of their IV cannulae monitored and recorded until removal due to various complications or routine changes.

Detailed description: This randomized controlled trial aims to investigate the impact of limb splinting on the lifespan of intravenous (IV) cannulae in neonates. The study is motivated by the need to enhance the efficacy and safety of peripheral IV cannulation in neonates, who frequently require intravenous access for the administration of medications and fluids during hospitalization. Peripheral IV cannulation, although common, is associated with a limited dwell time and various complications, including extravasation, occlusion, and leakage, which can lead to multiple cannulations and increased discomfort for neonates.

The study is designed to compare the lifespan of IV cannulae in neonates who have their limbs splinted with those who do not. The primary focus is on whether splinting the limb can effectively increase the dwell time of the IV cannula, thereby reducing the frequency of cannulation and associated complications. The trial involves 246 neonates, randomly assigned to either the splint or non-splint group, with an equal number of participants in each group.

Neonates included in the study will undergo standard peripheral IV cannulation procedures, with all cannulae being inserted by experienced medical staff under controlled conditions. In the splint group, the limb with the IV cannula will be immobilized using a splint, while in the non-splint group, the limb will not be splinted. The time from cannula insertion to removal will be meticulously recorded for each neonate, along with any complications that arise, such as extravasation, accidental dislodgment, infiltration, phlebitis, leakage, or occlusion.

Data will be collected using a self-designed questionnaire, ensuring that the information is only accessible to the primary investigator to maintain data integrity and confidentiality. The study will employ rigorous statistical analysis, including two-sample t-tests to compare the mean dwell times between the splinted and non-splinted groups, and Spearman's rank analysis to explore correlations between various parameters.

The outcomes of this trial are expected to provide valuable insights into the effectiveness of limb splinting as a technique for increasing the lifespan of IV cannulae in neonates. The findings could potentially influence clinical practices by identifying a simple yet effective method to enhance the safety and comfort of neonatal patients requiring IV therapy.

Eligibility criteria: Inclusion Criteria:

* All neonates with intravenous cannulae

Exclusion Criteria:

* All neonates in neonatal ICU
* All neonates with central venous line in place
* All neonates that are on ventilatory support

Primary outcomes:
measure: lifespan (dwell time) of the intravenous (IV) cannulae.
timeFrame: from 0 to 48 hours
Secondary outcomes:
measure: Incidence of Complications
timeFrame: from 0 to 48 hours
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Department of Pediatric Surgery,Holy Family Hospital
state: Punjab
Study officials:
affiliation: Rawalpindi Medical College
name: Ali Raza Chaudhry, MBBS, MS
role: STUDY_DIRECTOR
affiliation: Rawalpindi Medical College
name: Mudassar Fiaz Gondal, MBBS, MS
role: STUDY_CHAIR
affiliation: Rawalpindi Medical College
name: hasnain Aslam, MBBS
role: PRINCIPAL_INVESTIGATOR
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