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OpenTrials
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NCT Number: NCT05167318

Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit

Premature very low birth weight (VLBW) 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 dybiosis (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 40 VLBW infants for 4 weeks following birth. Infants will be randomized into 1 of 2 groups. Standardized oral care will be performed every 3-4 hours (Group 1) and every 12 hours (Group 2). Aim 1 will evaluate the feasibility of frequent standardized oral care, Aim 2 will compare the oral microbiome between groups, and Aim 3 will compare respiratory outcomes including the incidence of ventilator associated pneumonia, bronchopulmonary dysplasia and need for respiratory support between infants receiving standardized oral care every 3-4 hours and every 12 hours. Issues related to recruitment, retention, randomization, acceptance by nursing staff, and treatment fidelity will be examined. Saliva samples will be obtained weekly and analyzed using 16S sequencing, respiratory cultures will be obtained weekly on ventilated infants, and respiratory outcomes will be collected from the medical records.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age < 32 weeks
  • birth weight < 1500 grams
  • mother is English speaking
  • mother is > 18 years of age.

Exclusion criteria

  • Congenital anomalies of the face, lungs, or gastrointestinal system
  • not expected to survive

Treatment and study plan

frequent standardized oral care

Other

Standardized oral care will be provided every 3-4 hours

Primary outcomes

  1. Type of of bacterial in the oral cavity

    Time frame: weekly for 4 weeks

    microbial analysis of the oral microbiome

Secondary outcomes

  1. Days of respiratory support

    Time frame: Up to 100 days

    number of days infant was on respiratory support

  2. Incidence of chronic lung disease

    Time frame: Up to 100 days

    Whether or not the infant was diagnosed with chronic lung disease

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Dec 22, 2021
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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