Status:
COMPLETED
Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Agency for Healthcare Research and Quality (AHRQ)
Conditions:
Staph Aureus Colonization
Staph Aureus Infection
Eligibility:
All Genders
Phase:
NA
Brief Summary
This trial will test the hypothesis that treating parents of neonates requiring NICU care with intranasal mupirocin and topical chlorhexidine bathing will reduce the spread of S. aureus from parents t...
Detailed Description
The TREAT PARENTS Trial, or Treating Parents to Reduce NICU Transmission of S. aureus, is a placebo-controlled, double-masked, randomized clinical trial to test the hypothesis that treatment of S. aur...
Eligibility Criteria
Inclusion
- Neonate has never had a clinical or surveillance culture grow S. aureus
- Neonate was transferred from another hospital or admitted from home and had admission screening cultures for S. aureus colonization that were negative (if admission cultures were not performed, the cultures will be performed as part of the pre-randomization screening process)
- Parent(s) is(are) able to visit the child at the bedside
- Parent(s) test positive for S. aureus at screening
- Neonate has anticipated stay longer than 5 days in the NICU (if estimated stay is unclear, parents can be screened for S. aureus colonization and decision to randomize can be delayed until hospital day 3 or 4 after reassessment of anticipated stay).
- Parents is(are) willing to be randomized
- No documented or reported allergies to any agent used in either treatment regimen
- Able to perform written informed consent
Exclusion
- Allergies to any agent used in either treatment regimen
- Neonate has had a prior clinical or surveillance culture grow S. aureus
- Neonate admitted to NICU from home and is greater than 7 days of age
- Neonate admitted to NICU from another hospital and is greater than 7 days of age
- Neonate is a ward of the State
- Not able to provide written informed consent
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT02223520
Start Date
November 1 2014
End Date
October 31 2019
Last Update
January 11 2022
Active Locations (2)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287