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Neonatal Bacterial Colonization Study

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ClinicalTrials.gov Identifier: NCT03896893
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
John E. Fogarty International Center (FIC)
Information provided by (Responsible Party):
Angela Dramowski, University of Stellenbosch

Brief Summary:
This study will evaluate the effect of skin antisepsis and/or emollient therapy on bacterial colonization dynamics in very low birth weight, hospitalized infants. Bacterial swabs from 5 body sites will be collected at baseline, day 3, day 8 and day 13 following study arm assignment. Study outcomes include changes in bacterial colony counts, burden of gram-negative and gram-positive pathogens and overall skin score.

Condition or disease Intervention/treatment Phase
Neonatal SEPSIS Prematurity Very Low Birth Weight Baby Bloodstream Infection Other: Skin antisepsis Other: Emollient Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Enrolled babies will be sequentially recruited to one of 4 study arms (see below).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of 1% Chlorhexidine Gluconate and/or Emollient on Neonatal Bacterial Colonization Dynamics
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of Care
Routine bathing and skin care as per hospital practice
Experimental: 1% chlorhexidine gluconate (CHG)
1% aqueous CHG applied from the neck down with cotton swabs daily on weekdays (total of 8 days CHG application)
Other: Skin antisepsis
1% aqueous chlorhexidine gluconate

Experimental: Emollient therapy
Aquaphor skin cream applied from the neck down daily on weekdays (total of 8 days emollient application)
Other: Emollient
Aquaphor skin cream

Experimental: 1% CHG plus emollient therapy
1% aqueous CHG applied from the neck down with cotton swabs daily on weekdays followed immediately by Aquaphor skin cream (total of 8 days CHG application plus emollient application)
Other: Skin antisepsis
1% aqueous chlorhexidine gluconate

Other: Emollient
Aquaphor skin cream




Primary Outcome Measures :
  1. Change in median bacterial colony counts by body site over time [ Time Frame: baseline, day 3, day 8 and day 13 post enrolment ]
  2. Change in Gram negative pathogen burden by body site over time [ Time Frame: baseline, day 3, day 8 and day 13 post enrolment ]
  3. Change in Gram positive pathogen burden by body site over time [ Time Frame: baseline, day 3, day 8 and day 13 post enrolment ]
  4. Change in median skin condition score over time (Grading scale adapted by Darmstadt from Lane at al) [ Time Frame: Daily from enrolment to day 13 post enrolment ]
    Darmstadt skin score uses a 9-point scale (calculated as the sum of points for each of 3 items: skin eythema, dryness and breakdown, with a minimum score of 1 and maximum score of 3, representing worst possible skin condition for each sub-scale, total sum of points is a minimum score of 3 and maximum score of 9 for worst possible skin condition)


Secondary Outcome Measures :
  1. Incidence of laboratory-confirmed sepsis [ Time Frame: up until day 28 of life ]
    pathogen identified on sterile site specimen (blood, urine, cerebrospinal fluid)

  2. Incidence of clinically-suspected sepsis [ Time Frame: up until day 28 of life ]
    culture-negative episode of infection with at least 5 days broad-spectrum antibiotic therapy



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Birth weight ≥1000g and ≤ 1500g (equivalent to gestational age 28 - 32 weeks)
  • Day 1 or 2 or 3 of life
  • Anticipated length of hospital stay > 7 days.

Exclusion Criteria:

  • Birth weight <1000g or >1500g
  • Mother not present, unable or unwilling to provide consent for enrolment
  • Any skin condition or congenital defect that could potentially result in enhanced CHG absorption (skin blistering/bullae, congenital anomalies e.g. gastroschisis, spina bifida)
  • Anticipated length of hospital stay < 7 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896893


Contacts
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Contact: Angela Dramowski, MD, PhD +27219389506 dramowski@sun.ac.za

Locations
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South Africa
Tygerberg Hospital Recruiting
Cape Town, Western Cape, South Africa, 7503
Contact: Angela Dramowski, MD, PhD    +27219389506    dramowski@sun.ac.za   
Contact       dramowski@sun.ac.za   
Principal Investigator: Angela Dramowski, MD, PhD         
Sub-Investigator: Susan Coffin, MD         
Sub-Investigator: Mark Cotton, MD, PhD         
Sub-Investigator: Andrew Whitelaw, MD         
Sub-Investigator: Adrie Bekker, MD, PhD         
Sub-Investigator: Sheylyn Pillay, MD         
Sub-Investigator: Candice Macdonald, MD         
Sponsors and Collaborators
University of Stellenbosch
John E. Fogarty International Center (FIC)

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Responsible Party: Angela Dramowski, Associate Professor, University of Stellenbosch
ClinicalTrials.gov Identifier: NCT03896893     History of Changes
Other Study ID Numbers: N18/07/068
5K43TW010682 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Anticipated availability from first quarter 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neonatal Sepsis
Birth Weight
Body Weight
Signs and Symptoms
Sepsis
Infection
Infant, Newborn, Diseases
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Emollients
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents