RCT to analyse efficacy of double port extension tubing connection to peripheral IV cannula in prevention of neonatal late onset sepsis
DOI:
https://doi.org/10.18203/2349-3291.ijcp20251869Keywords:
Late onset sepsis, NICU, Intravenous cannula, Double port extension, Randomized control trialAbstract
Background: Late-onset sepsis (LOS), defined as sepsis occurring after 72 hours of age, causes substantial mortality and morbidity in neonates admitted in NICU. These neonates depend significantly on vascular access to administer fluids, nutrition, blood products and medication. This typically relies on the use of Peripheral Intravenous Cannula (PIVC) however, problems associated with IV infusion therapy include contamination of fluid with bacteria, endotoxins and particulates. Despite strict adherence to hygienic protocols, the incidence of nosocomial sepsis remains high. Incorporating an intravenous cannula with double port extension may be an effective strategy to reduce LOS. So, we did an open-label randomized controlled trial (RCT) to determine if the addition of a double port extension to an intravenous cannula can help in the prevention of LOS.
Methods: Open label randomized controlled trial was conducted in 300 newborns admitted in the Department of pediatrics, LLRM Medical college, Meerut from April 2023 to March 2024. Admitted neonates underwent a sepsis screen. Those with a negative sepsis screen were enrolled and then randomly assigned to the groups. Group A: Babies with an intravenous cannula with a double port extension; Group B: Babies with an intravenous cannula without double port extension
Results: 150 babies from each group were analysed. 13.34% and 43.34% were blood culture positive in each group respectively (p-value<0.001). 10% and 30% were sepsis screen positive in respective groups. 142 (94.67%) discharged, 1 (0.66%) expired and 133 (88.67%) discharged, 10 (6.66%) expired out of 150 babies in each group respectively.
Conclusions: The addition of a double port extension in the IV cannula shows a reduction in LOS when compared to the control.
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References
Pettit J. Fostering a new era of vascular access device selection in neonates. Newborn Infant Nurse Rev. 2006;6(4):186–92. DOI: https://doi.org/10.1053/j.nainr.2006.09.004
The Royal Children's Hospital Melbourne. Peripheral intravenous (IV) device management. 2018.
Dougherty L. Back to basics in IV therapy: an unfortunate necessity MA Healthcare London. Br J Nurs. 2008;17:3. DOI: https://doi.org/10.12968/bjon.2008.17.Sup8.31468
Baumgartner TG, Schmidt GL, Thakker KM. Bacterial endotoxin retention by inline intravenous filters. Am J Hosp Pharm. 1986;43:681-4. DOI: https://doi.org/10.1093/ajhp/43.3.681
O’Grady NP, Alexander M, Dellinger EP. Guidelines for the prevention of intravascular catheter-related infections. the hospital infection control practices advisory committee, center for disese control and prevention, U.S. Paediatrics. 2002;110:51.
Hayes R, Hartnett J, Semova G. Neonatal sepsis definitions from randomised clinical trials. Pediatr Res. 2021;6:768.
Wax DB, Shah A, Shah R, Lin HM, Katz D. Efficacy and Usability of a Novel Barrier Device for Preventing Injection Port Contamination: A Pilot Simulation Study. Anesth Analg. 2020;130(3):45-8. DOI: https://doi.org/10.1213/ANE.0000000000004235
Wuni FK, Kukeba MW, Dzotsi KSN, Osman A, Atobrah P, Ofosu-Poku R. Incidence of blood culture-related sepsis in neonates and antibiotics sensitivity of implicated organisms in a secondary healthcare facility in Ghana. Ghana Med J. 2023;57(2):134-40. DOI: https://doi.org/10.4314/gmj.v57i2.8
Al-Momani MM. Admission patterns and risk factors linked with neonatal mortality: A hospital-based retrospective study. Pak J Med Sci. 2020;36(6):1371-6. DOI: https://doi.org/10.12669/pjms.36.6.2281
Ismail SA, McCullough A, Guo S, Sharkey A, Harma S, Rutter P. Gender-related differences in care-seeking behaviour for newborns: a systematic review of the evidence in South Asia. BMJ Glob Health. 2019;9;4(3):76.
Saranappa SBS. "A study of disease pattern and outcome of newborns admitted to NICU in a tertiary care hospital. J Evol Med Dental Sci. 2012;5:75.
Demisse AG, Alemu F, Gizaw MA, Tigabu Z. Patterns of admission and factors associated with neonatal mortality among neonates admitted to the neonatal intensive care unit of University of Gendar Hospital, Northwest Ethiopia. Pediatric Health, Medicine and Therapautics. 2017;8:57–64. DOI: https://doi.org/10.2147/PHMT.S130309
Ali SR, Ahmed S, Lohana H. disease pattern and outcomes of neonatal admissions at a secondary care hospital in Pakistan. Sultan Qaboos Univ Med J. 2013;13(3):424–8. DOI: https://doi.org/10.18295/2075-0528.1498
Ogundare E, Akintayo A, Aladekomo T, Adeyemi L, Ogunlesi T, Oyelami O. Presentation and outcomes of early and late onset neonatal sepsis in a Nigerian Hospital. Afr Health Sci. 2019;19(3):2390-9. DOI: https://doi.org/10.4314/ahs.v19i3.12
Ali AA, Ahmed M, Noor SK, Mustafa L, Ibrahim W, ElAmin M, et al. The Relationship Between Blood Culture, C-reactive Protein and Neonatal Sepsis: A Cross-Sectional Study. Cureus. 2024;16(3):7. DOI: https://doi.org/10.7759/cureus.56813
Harsha G, Robert N. Late-onset Neonatal Sepsis—A 10-year Review From North Queensland, Australia. Pediat Infect Dis J. 2020;36(9):883-8. DOI: https://doi.org/10.1097/INF.0000000000001568
Charoo BA, Iqbal JI, Iqbal Q, Mushtaq S, Bhat AW, Nawaz I. Nosocomial sepsis-induced late onset thrombocytopenia in a neonatal tertiary care unit: a prospective study. Hematol Oncol Stem Cell Ther. 2009;2(2):349-53. DOI: https://doi.org/10.1016/S1658-3876(09)50024-6
Smith AB, Wilkinson-Faulk D. W-FD factors affecting the life span of peripheral intravenous lines in hospitalized infants. Pediatr Nurs. 1994;20 (6):543–547.
Birhane E, Kidanu K, Kassa M. Lifespan and associated factors of peripheral intravenous Cannula among infants admitted in public hospitals of Mekelle City, Tigray, Ethiopia, 2016. BMC Nurs. 2017;16(1):1–8. DOI: https://doi.org/10.1186/s12912-017-0227-1
Marsh N, Larsen EN, Takashima M, Kleidon T, Keogh S, Ullman AJ, et al. Peripheral intravenous catheter failure: A secondary analysis of risks from 11,830 catheters. Int J Nurs Stud. 2021;124:104095. DOI: https://doi.org/10.1016/j.ijnurstu.2021.104095