Catheter Biofilm Microbiome in Infected Neonatal Catheters.

NCT01985737 | Completed

• 2 other identifiers: H-33004Blood Stream Infections
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Percutaneously Inserted Central Catheters (PICCs) are special tubes that are inserted into blood vessels of premature babies (neonates) to give them nutrition and medications. Sometimes these tubes get infected and they need to be removed. Also, the babies need to be given medications to treat these infections (antibiotics). PICC infections in neonates are a serious problem and we need to find new ways of detecting infections early so that we can treat them promptly to avoid complications. The purpose of this study is to understand what causes tube infections in neonates and to develop a test to detect tube infections early to avoid complications.

Conditions

Catheter-associated Bloodstream Infections (CLABSI)

Keywords

Neonatal Intensive Care Units (NICUs); NICUs; Neonates; CLABSI; Microbiome; DNA signature; Catheter infections

Outcome Measures

Primary Outcomes (1)

• Determine the differences in the catheter biofilm microbiome from neonates with CLABSIs compared to those without CLABSI

  We will study catheters from neonates with CLABSIs and those without. We will correlate the catheter biofilm microbiome with catheter tip cultures and the skin microbiome at the catheter entry site.

  1 year

Secondary Outcomes (1)

• Determine the diagnostic accuracy of microbial DNA load for the detection of catheter infection

  1 year

Study Arms (2)

Infants with infected PICC line

After informed consent the subjects that develop a PICC line infection in the NICU will serve as the cases.

Other: Sample collection

Infants without infected PICC line

After informed consent the subjects that do not develop a PICC line infection in the NICU will serve as the controls.

Other: Sample collection

Interventions

Sample collection OTHER

Also known as: This is an observational biospecimen collection study.

Infants with infected PICC line; Infants without infected PICC line

Eligibility Criteria

• Age: 1 Day - 3 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All neonates admitted to Texas Children's Hospital (TCH) NICU with indwelling catheters will be recruited at the time of line insertion.

You may qualify if:

• Neonates with a percutaneously inserted central catheters (Neo PICC) who may or may not develop CLABSIs

You may not qualify if:

• Infants with known Immunodeficiency Syndrome

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Pammi M, Thapa S, Balderas M, Runge JK, Venkatachalam A, Luna RA. Microbiome signatures in neonatal central line associated bloodstream infections. PLoS One. 2020 Jan 16;15(1):e0227967. doi: 10.1371/journal.pone.0227967. eCollection 2020.

  PMID: 31945114 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

We will collect approximately 10 drops of blood from the infant for our research study. We will take the blood directly from the PICC tube when it is being removed. We will also take a skin swab from around the area where the PICC tube was placed.

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Mohan Pammi, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 15, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

US (1)