Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial (TREAT PARENTS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02223520|
Recruitment Status : Completed
First Posted : August 22, 2014
Results First Posted : March 16, 2020
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Staph Aureus Colonization Staph Aureus Infection||Drug: Mupirocin and Chlorhexidine Drug: Placebo ointment and placebo cloths||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||307 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Treating Parents to Reduce Neonatal Intensive Care Unit (NICU) Transmission of Staphylococcus Aureus|
|Actual Study Start Date :||November 2014|
|Actual Primary Completion Date :||October 31, 2019|
|Actual Study Completion Date :||October 31, 2019|
Active Comparator: 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.
Drug: Mupirocin and Chlorhexidine
Placebo Comparator: 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.
Drug: Placebo ointment and placebo cloths
- Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain [ Time Frame: Up to 90 days ]Primary outcome is neonatal acquisition of S. aureus strain that is concordant to parental S. aureus strain as determined by periodic surveillance cultures or a culture collected during routine clinical care that grows S. aureus. Survival analysis techniques will be used to compare the hazard of concordant colonization comparing Treatment and Control Groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223520
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Aaron Milstone, MD, MHS||Johns Hopkins University|