Clinical trial NCT02223520: Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial
Official title: Treating Parents to Reduce Neonatal Intensive Care Unit (NICU) Transmission of Staphylococcus Aureus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Staph Aureus Colonization
Staph Aureus Infection
Keywords: Staphylococcus aureus
Infection
Colonization
Transmission
Neonate
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2014-08-22
Enrollment: 307
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 to neonates.

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. 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.

Eligibility criteria: 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, 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 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

Primary outcomes:
measure: Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain
timeFrame: Up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Aaron Milstone, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milstone AM, Voskertchian A, Koontz DW, Khamash DF, Ross T, Aucott SW, Gilmore MM, Cosgrove SE, Carroll KC, Colantuoni E. Effect of Treating Parents Colonized With Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit: A Randomized Clinical Trial. JAMA. 2020 Jan 28;323(4):319-328. doi: 10.1001/jama.2019.20785.
citation: Milstone AM, Koontz DW, Voskertchian A, Popoola VO, Harrelson K, Ross T, Aucott SW, Gilmore MM, Carroll KC, Colantuoni E. Treating Parents to Reduce NICU Transmission of Staphylococcus aureus (TREAT PARENTS) trial: protocol of a multisite randomised, double-blind, placebo-controlled trial. BMJ Open. 2015 Sep 9;5(9):e009274. doi: 10.1136/bmjopen-2015-009274.