NCT03755635

Neonatal Sepsis at Neonatal Intensive Care Units in Ghana

Completed NA Last updated 11 October 2021

What this trial tests

NA trial testing The WHO multimodal hand hygiene strategy in Neonatal SEPSIS in 5,433 participants. Completed in 30 September 2019.

Timeline

1 October 2018

Primary endpoint
30 September 2019

30 September 2019

Quick facts

Lead sponsor	Stephanie Bjerrum
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	5,433
Start date	1 October 2018
Primary completion	30 September 2019
Estimated completion	30 September 2019
Sites	1 location across Ghana

Drugs / interventions tested

• The WHO multimodal hand hygiene strategy

Conditions studied

• Neonatal SEPSIS — all drugs for Neonatal SEPSIS →

Sponsor

Stephanie Bjerrum

Who can join

Adults 1 Minute to 48 Hours, any sex, with Neonatal SEPSIS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Neonatal sepsis is a major contributor to global under five mortality. In developing countries a major proportion of neonatal sepsis is thought to emanate from the healthcare setting, due to challenges in infection prevention practices.

Aim: To study the epidemiology of neonatal sepsis and evaluate the effect of multimodal infection control interventions on the incidence of neonatal sepsis; and colonization by multidrug resistant Gram negative bacteria (MDRGNB).

Methods: A controlled before and after interventional trial comprising a 7 month pre- intervention phase, 5 month intervention phase and 7 month post-intervention phase. Neonates admitted at the Neonatal Intensive Care Unit (NICU) at Korle-Bu Teaching Hospital (KBTH) will be enrolled prospectively and followed up for diagnosis of sepsis and outcome of admission. This will be used to describe the epidemiology of neonatal sepsis. Swabs will be collected from a subpopulation of included neonates at intervention site (KBTH) and control site (37 Military Hospital) NICUs to assess colonization of neonates with MDRGNB. Environmental swabs will be collected from surfaces at the NICU to assess MDRGNB contamination of the environment. The intervention comprises infection prevention strategies including implementation of the WHO multimodal hand hygiene strategy. The primary endpoint is incidence of neonatal sepsis.

Expected Outcome: This study will contribute to improved infection prevention practices in the participating NICUs and highlight lessons which other national and regional NICUs may learn from.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. High Carriage Rates of Multidrug-Resistant Gram-Negative Bacteria in Neonatal Intensive Care Units From Ghana.
   Labi AK, Bjerrum S, Enweronu-Laryea CC, Ayibor PK, et al · · 2020 · cited 37× · PMID 32373647 · DOI 10.1093/ofid/ofaa109
2. Hand hygiene for the prevention of infections in neonates.
   Kuti BP, Ogunlesi TA, Oduwole O, Oringanje CC, et al · · 2023 · cited 5× · PMID 37278689 · DOI 10.1002/14651858.cd013326.pub4
3. Hand hygiene for the prevention of infections in neonates.
   Kuti BP, Ogunlesi TA, Oduwole O, Oringanje C, et al · · 2021 · cited 4× · PMID 33471367 · DOI 10.1002/14651858.cd013326.pub2