Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Oct 18;5(1):e001224.
doi: 10.1136/bmjpo-2021-001224. eCollection 2021.

I-KID study protocol: evaluation of efficacy, outcomes and safety of a new infant haemodialysis and ultrafiltration machine in clinical use: a randomised clinical investigation using a cluster stepped-wedge design

Heather J Lambert  1   2 , Shriya Sharma  3 , John N S Matthews  4
Affiliations

I-KID study protocol: evaluation of efficacy, outcomes and safety of a new infant haemodialysis and ultrafiltration machine in clinical use: a randomised clinical investigation using a cluster stepped-wedge design

Heather J Lambert et al. BMJ Paediatr Open. .

Abstract

Introduction: The I-KID study aims to determine the clinical efficacy, outcomes and safety of a novel non-CE-marked infant haemodialysis machine, the Newcastle Infant Dialysis Ultrafiltration System (NIDUS), compared with currently available therapy in the UK. NIDUS is specifically designed for renal replacement therapy in small babies between 0.8 and 8 kg.

Methods and analysis: The clinical investigation is taking place in six UK centres. This is a randomised clinical investigation using a cluster stepped-wedge design. The study aims to recruit 95 babies requiring renal replacement therapy in paediatric intensive care units over 20 months.

Ethics and dissemination: The study has high parent and public involvement at all stages in its design and parents will be involved in dissemination of results to parents and professionals via publications, conference proceedings and newsletters. The study has has ethics permissions from Tyne and Wear South Research Ethics Committee.

Trial registration numbers: IRAS ID number: 170 481MHRA Reference: CI/2017/0066ISRCT Number: 13 787 486CPMS ID number: 36 558NHS REC reference: 16/NE/0008Eudamed number: CIV-GB-18-02-023105Link to full protocol v6.0: https://fundingawards.nihr.ac.uk/award/14/23/26.

Keywords: neonatology; nephrology; technology.

PubMed Disclaimer

Conflict of interest statement

Competing interests: Dr Malcolm Coulthard is named on the patent and will receive some royalties if the NIDUS device goes into commercial production. The Newcastle upon Tyne NHS Foundation Trust will receive some royalties if the NIDUS device goes into commercial production.Allmed, the device manufacturers, are providing 17 NIDUS devices for loan to sites for the I-KID study and for potential compassionate use in the post-study period. NIDUS consumables are purchased as per normal clinical care. The rest of the authors have completed the COI form and have no competing interests to declare.

Figures

Figure 1
Figure 1
I-KID study design. NIDUS, Newcastle Infant Dialysis Ultrafiltration System; SW, stepped-wedge.
Figure 2
Figure 2
Patient data collection timeline: haemodialysis/filtration devices.
Figure 3
Figure 3
Patient data collection timeline: peritoneal dialysis. PD, peritoneal dialysis.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Tal L, Angelo JR, Akcan-Arikan A. Neonatal extracorporeal renal replacement therapy-a routine renal support modality? Pediatr Nephrol 2016;31:2013–5. 10.1007/s00467-016-3423-4 - DOI - PubMed
    1. Lee ST, Cho H. Fluid overload and outcomes in neonates receiving continuous renal replacement therapy. Pediatr Nephrol 2016;31:2145–52. 10.1007/s00467-016-3363-z - DOI - PubMed
    1. Coulthard MG, Crosier J, Griffiths C, et al. . Haemodialysing babies weighing <8 kg with the Newcastle infant dialysis and ultrafiltration system (Nidus): comparison with peritoneal and conventional haemodialysis. Pediatr Nephrol 2014;29:1873–81. 10.1007/s00467-014-2923-3 - DOI - PMC - PubMed
    1. Sutherland SM, Alexander SR. Continuous renal replacement therapy in children. Pediatr Nephrol 2012;27:2007–16. 10.1007/s00467-011-2080-x - DOI - PubMed
    1. Westrope CA, Fleming S, Kapetanstrataki M, et al. . Renal replacement therapy in the critically ill child. Pediatr Crit Care Med 2018;19:210–7. 10.1097/PCC.0000000000001431 - DOI - PubMed

Publication types