Treating Parents to Reduce NICU Transmission of Staphylococcus aureus (TREAT PARENTS) trial: protocol of a multisite randomised, double-blind, placebo-controlled trial.
BACKGROUND
More than 33,000 healthcare-associated infections occur in neonatal intensive care units (NICUs) each year in the USA. Parents, rather than healthcare workers, may be a reservoir from which neonates acquire Staphylococcus aureus (S. aureus) colonisation in the NICU. This study looks to measure the effect of treating parents with short course intranasal mupirocin and topical chlorhexidine antisepsis on acquisition of S. aureus colonisation and infection in neonates.


METHODS
The TREAT PARENTS trial (Treating Parents to Reduce Neonatal Transmission of S. aureus) is a multicentre randomised, masked, placebo-controlled trial. Shortly after a neonate is admitted to the NICU, parents will be tested for S. aureus colonisation. If either parent screens positive for S. aureus, then both parents as a pair will be enrolled and randomised to one of the two possible masked treatment arms. Arm 1 will include assignment to intranasal 2% mupirocin plus topical antisepsis with chlorhexidine gluconate impregnated cloths for 5 days. Arm 2 will include assignment to placebo ointment and placebo cloths for skin antisepsis for 5 days. The primary outcome will be neonatal acquisition of an S. aureus strain that is concordant to the parental baseline S. aureus strain as determined by periodic surveillance cultures or a culture collected during routine clinical care that grows S. aureus. Secondary outcomes will include neonatal acquisition of S. aureus, neonatal S. aureus infection, eradication of S. aureus colonisation in parents, natural history of S. aureus colonisation in parents receiving placebo, adverse reactions to treatment, feasibility of intervention, and attitudes and behaviour in consented parents. Four hundred neonate-parent pairs will be enrolled.


BACKGROUND
The study was approved by Johns Hopkins University IRB in June 2014 (IRB number 00092982). Protocol V.7 was approved in November 2014. Findings will be published in peer-reviewed journals.


BACKGROUND
NCT02223520.
Department of Pediatrics, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Aaron M
AM
Milstone
Department of Pediatrics, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Danielle W
http://orcid.org/0000-0002-0380-8318
DW
Koontz
Department of Pediatrics, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Annie
A
Voskertchian
Department of Pediatrics, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Victor O
VO
Popoola
Department of Pediatrics, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Kathleen
K
Harrelson
Department of Pathology, Division of Medical Microbiology, The Johns Hopkins Hospital, Baltimore, Maryland, USA.
Tracy
T
Ross
Department of Pediatrics, Division of Neonatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Susan W
SW
Aucott
Department of Pediatrics, Division of Neonatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Maureen M
MM
Gilmore
Department of Pathology, Division of Medical Microbiology, The Johns Hopkins Hospital, Baltimore, Maryland, USA.
Karen C
KC
Carroll
Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Elizabeth
E
Colantuoni
D000281:Administration, Intranasal; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D002648:Child; D002710:Chlorhexidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D003428:Cross Infection / Q000517:prevention & control; D004203:Disinfection / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D017053:Infection Control / Q000379:methods; D007363:Intensive Care Units, Neonatal; D016712:Mupirocin / Q000008:administration & dosage*; D010290:Parents; D013203:Staphylococcal Infections / Q000382:microbiology / Q000517:prevention & control*; D013211:Staphylococcus aureus / Q000302:isolation & purification
D000900:Anti-Bacterial Agents; D000891:Anti-Infective Agents, Local; D016712:Mupirocin; C010882:chlorhexidine gluconate; D002710:Chlorhexidine
MICROBIOLOGY; NEONATOLOGY