Neonatal Sepsis at Neonatal Intensive Care Units in Ghana

NCT03755635 | Completed

• 1 other identifier: UM ID: 892333
• Study Type: interventional
• Target: 5,433
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neonatal sepsis; Infection control; Hand hygiene; WHO multi modal

Outcome Measures

Primary Outcomes (1)

• Incidence of neonatal sepsis

  Incidence of neonatal sepsis including clinical cases treated as sepsis and cases of neonatal sepsis with confirmed bloodstream infections per 1000 admissions.

  Post-intervention at 7 months

Secondary Outcomes (4)

• Rate of hand hygiene compliance per opportunity

  Post-intervention at 7 months

• Rate of MDR Gram negative bacteria colonization among neonates

  During intervention at 2 months and post-intervention at 7 months

• Length of admission in days

  Post-intervention at 7 months

• All-cause mortality

  Post-intervention at 7 months

Study Arms (2)

Standard of care

NO INTERVENTION

Continuously monitoring of neonatal sepsis under standard of care at one site

Hand hygiene

EXPERIMENTAL

The WHO multimodal hand hygiene strategy is implemented at one site

Combination Product: The WHO multimodal hand hygiene strategy

Interventions

The WHO multimodal hand hygiene strategy COMBINATION_PRODUCT

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.

Also known as: Hand hygiene

Hand hygiene

Eligibility Criteria

• Age: 1 Minute - 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Admission NICU
• Birth weight ≥750 Grams
• ≤48 hours of age at time of enrolment
• Consent to participate obtained from legal guardian

You may not qualify if:

• Neonates with severe congenital malformations
• Neonates who have undergone surgical procedure

Sponsors & Collaborators

• Stephanie Bjerrum: lead
• University of Copenhagen: collaborator
• Korle-Bu Teaching Hospital, Accra, Ghana: collaborator
• Rigshospitalet, Denmark: collaborator
• University of Ghana: collaborator

Study Sites (1)

Korle Bu Teaching Hospital

Accra, Ghana

Location

Related Publications (1)

• Labi AK, Enweronu-Laryea CC, Nartey ET, Bjerrum S, Ayibor PK, Andersen LP, Newman MJ, Kurtzhals JAL. Bloodstream Infections at Two Neonatal Intensive Care Units in Ghana: Multidrug Resistant Enterobacterales Undermine the Usefulness of Standard Antibiotic Regimes. Pediatr Infect Dis J. 2021 Dec 1;40(12):1115-1121. doi: 10.1097/INF.0000000000003284.

  PMID: 34561387 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Hand Hygiene

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hygiene; Therapeutics; Public Health; Environment and Public Health

Study Officials

• Appiah Korang Labi, MD

  Department of Int. Health and Immunlogy Microbiology, University og Copenhagen

  PRINCIPAL INVESTIGATOR

• Jørgen Kurtzhals, Professor

  Department of Int. Health and Immunlogy Microbiology, University og Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PHD, postdoc

Model Details: Controlled before and after interventional trial

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 28, 2018
• Study Start: October 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

GH (1)