Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial

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 they 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.

Inclusion Criteria:

- 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, they 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 Criteria:

- 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