Prematurity Clinical Trial
Official title:
Impact of 1% Chlorhexidine Gluconate and/or Emollient on Neonatal Bacterial Colonization Dynamics
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 3 Days |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
South Africa | Tygerberg Hospital | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
University of Stellenbosch | John E. Fogarty International Center (FIC) |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in median bacterial colony counts by body site over time | baseline, day 3, day 8 and day 13 post enrolment | ||
Primary | Change in Gram negative pathogen burden by body site over time | baseline, day 3, day 8 and day 13 post enrolment | ||
Primary | Change in Gram positive pathogen burden by body site over time | baseline, day 3, day 8 and day 13 post enrolment | ||
Primary | Change in median skin condition score over time (Grading scale adapted by Darmstadt from Lane at al) | 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) | Daily from enrolment to day 13 post enrolment | |
Secondary | Incidence of laboratory-confirmed sepsis | pathogen identified on sterile site specimen (blood, urine, cerebrospinal fluid) | up until day 28 of life | |
Secondary | Incidence of clinically-suspected sepsis | culture-negative episode of infection with at least 5 days broad-spectrum antibiotic therapy | up until day 28 of life |
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