Neonatal Sepsis at Neonatal Intensive Care Units in Ghana

Summary

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.

Conditions

• Neonatal SEPSIS

Interventions

COMBINATION_PRODUCT

The WHO multimodal hand hygiene strategy

Comprises five essential elements; system change-availability of alcohol-based hand rub at the point of care and/ or access to safe continuous water supply and soap and towels; training and education of healthcare professionals; monitoring of hand hygiene practices and performance feedback; reminders in the workplace; and the creation of a hand hygiene safety culture with the participation of both individual healthcare workers and senior hospital managers.

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• Korle-Bu Teaching Hospital, Accra, Ghana

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• University of Ghana

  collaborator OTHER

• Stephanie Bjerrum

  lead OTHER

Principal Investigators

• Appiah Korang Labi, MD · Department of Int. Health and Immunlogy Microbiology, University og Copenhagen

• Jørgen Kurtzhals, Professor · Department of Int. Health and Immunlogy Microbiology, University og Copenhagen

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Minute

Max Age

48 Hours

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-10-01

Primary Completion

2019-09-30

Completion

2019-09-30

Countries

• Ghana

Study Locations