Prevention of Nosocomial Bacteremia Among Zambian Neonates

NCT02386592 | Completed DMC

• 1 other identifier: H-33473
• Study Type: interventional
• Target: 9,410
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to estimate the burden of disease, identify risk factors associated with nosocomial bacteremia among neonates and assess the efficacy of low-cost measures targeted to known and suspected nosocomial BSI (bloodstream) risk factors, the investigators propose to study the impact of a novel package of infection control interventions on nosocomial bacteremia and mortality among neonates at a tertiary care center in sub-Saharan Africa.

Conditions

Neonatal Sepsis; Neonatal Mortality

Outcome Measures

Primary Outcomes (1)

• All-cause neonatal mortality in hospitalized neonates

  in hospitalized neonates at University Teaching Hospital (UTH), a large tertiary referral center, in Zambia before and after the introduction of low-cost infection-control interventions.

  18 months

Secondary Outcomes (3)

• Incidence of nosocomial bacteremia in hospitalized neonates

  18 months

• Attributable risk of maternal, neonatal, hospital factors and nosocomial bacteremia among hospitalized neonates

  18 months

• Prevalence of nosocomial bacteremia caused by MDR-GNR infections among hospitalized neonates

  18 months

Study Arms (1)

Intervention

EXPERIMENTAL

Infection control package consisting of alcohol hand rub hand hygiene (HH), 2% chlorhexidine gluconate (CHG) body washes, infection control training, and text messages with basic Infection control reminders via SMS text

Drug: Chlorhexidine gluconate (CHG); Behavioral: Hand hygiene (HH); Behavioral: Infection control training; Other: Infection control reminders via SMS text

Interventions

Chlorhexidine gluconate (CHG) DRUG

All enrolled neonates admitted to the NICU during the implementation and intervention periods will undergo CHG bathing (sparing head and face) at the time of admission at and thereafter once weekly.

Also known as: 2% chlohexidine gluconate body wash

Intervention

Hand hygiene (HH) BEHAVIORAL

Alcohol hand rub will be produced in the hospital pharmacy and will be readily available in the NICU (via wall-mounted dispensers) throughout the intervention period. Hand hygiene among NICU physicians and nurses will actively be promoted through the intervention period.

Intervention

Infection control training BEHAVIORAL

All NICU healthcare workers will receive infection prevention training which will involve structure training on HH, universal precautions, neonatal skin antisepsis and peripheral IV placement and line care.

Intervention

Infection control reminders via SMS text OTHER

Infection control practice reminders will be sent to NICU healthcare workers on a daily basis via SMS messages.

Intervention

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates admitted to the study site NICU during the study period (including both "inborn" and "outborn" neonates)

You may not qualify if:

• Neonates without documented birth date
• Parent or guardian unavailable or unwilling to provide consent

Sponsors & Collaborators

• Boston University: lead
• University Teaching Hospital, Lusaka, Zambia: collaborator
• Zambia Center for Applied Health Research and Development: collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

University Teaching Hospital

Lusaka, 10101, Zambia

Location

Related Publications (4)

• Gill CJ, Mantaring JB, Macleod WB, Mendoza M, Mendoza S, Huskins WC, Goldmann DA, Hamer DH. Impact of enhanced infection control at 2 neonatal intensive care units in the Philippines. Clin Infect Dis. 2009 Jan 1;48(1):13-21. doi: 10.1086/594120.

  PMID: 19025496 BACKGROUND

• Aiken AM, Mturi N, Njuguna P, Mohammed S, Berkley JA, Mwangi I, Mwarumba S, Kitsao BS, Lowe BS, Morpeth SC, Hall AJ, Khandawalla I, Scott JAG; Kilifi Bacteraemia Surveillance Group. Risk and causes of paediatric hospital-acquired bacteraemia in Kilifi District Hospital, Kenya: a prospective cohort study. Lancet. 2011 Dec 10;378(9808):2021-2027. doi: 10.1016/S0140-6736(11)61622-X. Epub 2011 Nov 29.

  PMID: 22133536 BACKGROUND

• Milstone AM, Elward A, Song X, Zerr DM, Orscheln R, Speck K, Obeng D, Reich NG, Coffin SE, Perl TM; Pediatric SCRUB Trial Study Group. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet. 2013 Mar 30;381(9872):1099-106. doi: 10.1016/S0140-6736(12)61687-0. Epub 2013 Jan 28.

  PMID: 23363666 BACKGROUND

• Mwananyanda L, Pierre C, Mwansa J, Cowden C, Localio AR, Kapasa ML, Machona S, Musyani CL, Chilufya MM, Munanjala G, Lyondo A, Bates MA, Coffin SE, Hamer DH. Preventing Bloodstream Infections and Death in Zambian Neonates: Impact of a Low-cost Infection Control Bundle. Clin Infect Dis. 2019 Sep 27;69(8):1360-1367. doi: 10.1093/cid/ciy1114.

  PMID: 30596901 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

chlorhexidine gluconate; 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

• Davidson H Hamer, MD

  BU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: March 12, 2015
• Study Start: September 1, 2015
• Primary Completion: April 15, 2017
• Study Completion: July 1, 2017
• Last Updated: July 31, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 12 months after publication of the main study findings and full microbiological analysis
• Access Criteria: Upon receipt and review of an acceptable proposal for analysis of the data, we will share the database.

Locations

ZA (1)