Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02223520 |
Other study ID # |
NA_00092982 |
Secondary ID |
R01HS022872 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 2014 |
Est. completion date |
October 31, 2019 |
Study information
Verified date |
March 2020 |
Source |
Johns Hopkins University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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 to neonates.
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. aureus colonized parents with intranasal mupirocin and topical chlorhexidine
gluconate antisepsis will decrease neonatal S. aureus acquisition. All neonates admitted to
the Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center NICUs will be
pre-screened and parents will be approached for enrollment in the study. After consent and
baseline screening, 400 neonate-parent pairs will be randomized; only neonates who have a
parent colonized with S. aureus will be randomized. Parents will receive a 5 day treatment
with intranasal mupirocin plus topical chlorhexidine gluconate antisepsis or placebo.
After recruitment and informed consent, parents will undergo pre-randomization screening. If
both parents screen negative for S. aureus colonization, the neonate will be ineligible for
the randomization and parents will be informed that the parents are not colonized at that
time with S. aureus. If either parent screens positive for S. aureus, then both parents as a
pair will be eligible for randomization to one of the two possible masked treatment arms. The
neonate-parent "pair" will be the unit of randomization and each parent will be allocated to
the same group if both consent.
After the baseline neonate testing for S. aureus colonization, repeat testing will be
performed every 7 days for the neonates until the neonate acquires S. aureus colonization or
is discharged from the NICU.