Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial

NCT ID: NCT02223520

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2019-10-31

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.

Conditions

Staph Aureus Colonization; Staph Aureus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Mupirocin and Chlorhexidine

Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.

Group Type: ACTIVE_COMPARATOR

Mupirocin and Chlorhexidine

Intervention Type: DRUG

Placebo ointment and placebo cloths

Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.

Group Type: PLACEBO_COMPARATOR

Placebo ointment and placebo cloths

Intervention Type: DRUG

Interventions

Mupirocin and Chlorhexidine

Intervention Type: DRUG

Placebo ointment and placebo cloths

Intervention Type: DRUG

Other Intervention Names

bactroban; chlorhexidine gluconate

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Milstone, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31886828 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26353875 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HS022872

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

NA_00092982

Identifier Type: -

Identifier Source: org_study_id