Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial

• Status: Completed
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Agency for Healthcare Research and Quality (AHRQ)
• Treatments: Chlorhexidine; Chlorhexidine gluconate; Mupirocin

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