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Neonatal SepsisNCT02386592

Prevention of Nosocomial Bacteremia Among Zambian Neonates

A study testing Chlorhexidine gluconate (CHG) and Hand hygiene (HH) in people with Neonatal Sepsis and Neonatal Mortality, run by Boston University at 1 site in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 hour to 28 days
Conditions the study is for
Neonatal Sepsis, Neonatal Mortality
What is being tested?
Chlorhexidine gluconate (CHG) and Hand hygiene (HH)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,410 participants
Where
1 siteZambia
Study dates
1 Sep 2015to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 hour to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Zambia1 site

  • University Teaching Hospital

    Lusaka, 10101

Other trials in Zambia

About this study

Official title: Prevention of Nosocomial Bacteremia and Mortality Among Neonates at a Tertiary Referral Center in Zambia

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.

Read the detailed description

The study is an18 month prospective quasi-experimental evaluation of nosocomial bacteremia and mortality among hospitalized neonates and will consist of a 6-month baseline period to capture the incidence and all-cause mortality of nosocomial BSIs, a 1-month implementation period of low-cost infection control strategies (including alcohol-based hand rub [AHR], 2% chlorhexidine gluconate [CHG], hospital staff education and text message-based reminders of infection control recommendation) and an 11-month intervention period.

All neonates admitted to the neonatal intensive care unit (NICU) of the University Teaching Hospital (UTH) in Lusaka, Zambia during the study period will be eligible for study enrollment. This study will determine the capacity of an innovative bundle of low cost, simple and locally available interventions that leverage new technologies and expand application of highly effective interventions in order to reduce the incidence of nosocomial bacteremia among NICU patients in a developing country setting.

Being tested
Chlorhexidine gluconate (CHG), Hand hygiene (HH), Infection control training, Infection control reminders via SMS text
Medical subject headings
Neonatal Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chlorhexidine gluconate (CHG)Drug

    Also called 2% chlohexidine gluconate body wash

    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.

  • Hand hygiene (HH)Behavioural

    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.

  • Infection control trainingBehavioural

    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.

  • Infection control reminders via SMS textOther

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

Study groups in NCT02386592
Study groupRoleWhat they receive
InterventionExperimentalInfection 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
Receives: Drug: Chlorhexidine gluconate (CHG); Behavioral: Hand hygiene (HH); Behavioral: Infection control training; Other: Infection control reminders via SMS text

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 18 months

Secondary outcomes (3)

  1. Incidence of nosocomial bacteremia in hospitalized neonates

    Incidence of nosocomial bacteremia in hospitalized neonates at UTH before and after the introduction of low-cost infection-control interventions.

    Measured: 18 months

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

    Measure the attributable risk of maternal, neonatal and hospital factors as well as invasive procedures on nosocomial bacteremia among neonates hospitalizedat UTH

    Measured: 18 months

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

    Prevalence of nosocomial bacteremia caused by MDR-GNR infections among neonates at UTH.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2015 (estimated)
  2. Study start1 Sep 2015
  3. Primary completion15 Apr 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9,410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02386592
Sponsor's protocol ID
H-33473
Status last verified
Jul 2017
First submitted
17 Feb 2015
Last updated
31 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We are willing to share participant and microbiological data after publication of the main study findings and after receipt of an acceptable analysis plan.

Publications

  • 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.

    PubMed 19025496

  • 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.

    PubMed 22133536

  • 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.

    PubMed 23363666

  • 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.

    PubMed 30596901

Questions about this trial

What is this clinical trial studying?

A study testing Chlorhexidine gluconate (CHG) and Hand hygiene (HH) in people with Neonatal Sepsis and Neonatal Mortality, run by Boston University at 1 site in Zambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause neonatal mortality in hospitalized neonates (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02386592, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.

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