Limb Splinting for Intravenous Cannulae in Neonates and Its Effects on Life Span of Intravenous Cannulae

NCT06615063 | Completed

• 1 other identifier: RMU-RRF-SUR-007-23
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Peripheral Intravenous Cannulation; Limb Splinting; Intravenous Cannula Lifespan; Extravasation; Extravasation Injury

Keywords

Neonatal Care; Intravenous Cannulation; Splinting; Neonatal Surgery; Pediatric Surgery; Extravasation

Outcome Measures

Primary Outcomes (1)

• lifespan (dwell time) of the intravenous (IV) cannulae.

  The study aims to compare the mean dwell time of IV cannulae between the splinted and non-splinted groups to determine if limb splinting has a significant effect on extending the duration for which the cannula remains functional before removal.

  from 0 to 48 hours

Secondary Outcomes (1)

• Incidence of Complications

  from 0 to 48 hours

Study Arms (2)

Splint Group

EXPERIMENTAL

These neonates receive peripheral intravenous cannulation with limb splinting.

Other: Hasi's Splint

Non-Splint Group

NO INTERVENTION

These neonates receive peripheral intravenous cannulation without limb splinting.

Interventions

Hasi's Splint OTHER

A splint made up of cotton and gauze piece rolled over a hard cardboard piece and covered by adhesive tape was applied to the limb immediately after fixing the cannula, as per the standardised method, to prevent movement at the underlying joint. Dimensions of the splints used were standardised as length extending two and a half inches on either side of the joint and width equal to the width of the limb just proximal to the joint.

Splint Group

Eligibility Criteria

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

You may qualify if:

• All neonates with intravenous cannulae

You may not qualify if:

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

Sponsors & Collaborators

• Rawalpindi Medical College: lead

Study Sites (1)

Department of Pediatric Surgery,Holy Family Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (11)

• Barker DP, Rutter N. Exposure to invasive procedures in neonatal intensive care unit admissions. Arch Dis Child Fetal Neonatal Ed. 1995 Jan;72(1):F47-8. doi: 10.1136/fn.72.1.f47.

  PMID: 7743285 RESULT

• Bakr AF. Intravenous lines-related sepsis in newborn babies admitted to NICU in a developing country. J Trop Pediatr. 2003 Oct;49(5):295-7. doi: 10.1093/tropej/49.5.295.

  PMID: 14604163 RESULT

• Gupta P, Rai R, Basu S, Faridi MM. Life span of peripheral intravenous cannula in a neonatal intensive care unit of a developing country. J Pediatr Nurs. 2003 Aug;18(4):287-92. doi: 10.1016/s0882-5963(03)00052-6.

  PMID: 12923741 RESULT

• Mewahegn AA, Tadesse B, GebreEyesus FA, Tarekegn TT, Amlak BT, Emeria MS, Temere BC, Terefe TF, Zewudie BT, Geletie HA, Mengist ST. Lifespan and Associated Factors of Peripheral Intravenous Cannula Among Hospitalized Children in Public Hospitals of the Gurage Zone, Ethiopia, 2021. Pediatric Health Med Ther. 2022 Mar 25;13:81-93. doi: 10.2147/PHMT.S351759. eCollection 2022.

  PMID: 35368745 RESULT

• Franck LS, Hummel D, Connell K, Quinn D, Montgomery J. The safety and efficacy of peripheral intravenous catheters in ill neonates. Neonatal Netw. 2001 Aug;20(5):33-8. doi: 10.1891/0730-0832.20.5.33.

  PMID: 12144220 RESULT

• Birhane E, Kidanu K, Kassa M, Gerezgiher D, Tsegay L, Weldu B, Kidane G, Gerensea H. Lifespan and associated factors of peripheral intravenous Cannula among infants admitted in public hospitals of Mekelle City, Tigray, Ethiopia, 2016. BMC Nurs. 2017 Jun 15;16:33. doi: 10.1186/s12912-017-0227-1. eCollection 2017.

  PMID: 28638278 RESULT

• Dalal SS, Chawla D, Singh J, Agarwal RK, Deorari AK, Paul VK. Limb splinting for intravenous cannulae in neonates: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2009 Nov;94(6):F394-6. doi: 10.1136/adc.2008.147595. Epub 2009 May 12.

  PMID: 19439433 RESULT

• Morris W, Heong Tay M. Strategies for preventing peripheral intravenous cannula infection. Br J Nurs. 2008 Oct 23-Nov 12;17(19):S14-21. doi: 10.12968/bjon.2008.17.Sup8.31470.

  PMID: 18974681 RESULT

• Johnson RV, Donn SM. Life span of intravenous cannulas in a neonatal intensive care unit. Am J Dis Child. 1988 Sep;142(9):968-71. doi: 10.1001/archpedi.1988.02150090066024.

  PMID: 3414629 RESULT

• Shenoy S, Karunakar BP. Factors influencing the peripheral venous catheter survival in critically ill children in a pediatric intensive care unit. Indian J Pediatr. 2014 Dec;81(12):1293-6. doi: 10.1007/s12098-014-1430-7. Epub 2014 May 6.

  PMID: 24796410 RESULT

• Serane V T, Rajasekaran R, Vijayadevagaran V, Kothendaraman B. Peripheral intravenous cannulae in neonates: To splint or not? J Vasc Access. 2022 May;23(3):398-402. doi: 10.1177/1129729821996926. Epub 2021 Feb 23.

  PMID: 33619983 RESULT

Study Officials

• Ali Raza Chaudhry, MBBS, MS

  Rawalpindi Medical College

  STUDY DIRECTOR

• Mudassar Fiaz Gondal, MBBS, MS

  Rawalpindi Medical College

  STUDY CHAIR

• hasnain Aslam, MBBS

  Rawalpindi Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The description of the study does not explicitly mention any masking (blinding). In the context provided, the primary investigator collects and analyzes the data using self-designed questionnaires. Typically, in such studies, the intervention (splinting) would be known to the participants and the healthcare providers administering the IV cannulation. Therefore, masking of the participants and providers might not be feasible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: September 26, 2024
• Study Start: December 10, 2022
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)