RECRUITING

Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Premature infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dysbiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 168 VLBW infants for 4 weeks following birth.

Official Title

Frequent Standardized Oral Care Using Human Milk to Prevent Oral Dysbiosis and Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit

Quick Facts

Study Start:2023-11-23
Study Completion:2026-12-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06000761

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Hour to 3 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Leslie A Parker, PhD, APRN
CONTACT
352-273-6384
parkela@ufl.edu

Principal Investigator

Leslie Parker, PHD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
Gainesville, Florida, 32504
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Leslie Parker, PHD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-23
Study Completion Date2026-12-20

Study Record Updates

Study Start Date2023-11-23
Study Completion Date2026-12-20

Terms related to this study

Additional Relevant MeSH Terms

  • Ventilator Associated Pneumonia
  • Bronchopulmonary Dysplasia
  • Respiratory Disease