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NCT Number: NCT06000761

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

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.

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Key information

Age range

1 hour–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida

Gainesville, Florida, 32504, United States

Location status: Recruiting

Location contact

Leslie A Parker, PhD

CONTACT

[email protected]

352-215-9360

Leslie A Parker, PhD

PRINCIPAL_INVESTIGATOR

About this study

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 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. Premature VLBW infants are highly susceptible to costly, life threatening and potentially preventable morbidities, such as ventilator associated pneumonia (VAP), bronchopulmonary dysplasia (BPD; oxygen requirement at 28 days of life) and need for prolonged respiratory support which require additional treatments, increase cost of care, and can lead to chronic illness, re-hospitalization, and developmental delay. A dearth of information exists regarding oral care in VLBW infants, and no such guidelines exist for infants admitted to the neonatal intensive care unit (NICU) which may negatively affect their health. Thus, research regarding the effect of frequent, standardized oral care on the health of VLBW infants is essential to develop guidelines thus potentially improving the health of this vulnerable population. If successful, this research could change practice in NICUs across the nation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion:

  • Mother ≥18 years of age
  • ≤ 30 weeks gestation
  • Born weighing ≤ 1500 grams

Exclusion:

  • Congenital anomalies of the face, lungs, or gastrointestinal system
  • Not expected to live > 7 days following delivery.

Treatment and study plan

Standardized oral Care

Procedure

One sponge-tipped swab, saturated with sterile water or human milk, will used clean the oral cavity with 15 seconds each area. Surfaces include all 4 quadrants of the gum surface and upper posterior part of the oropharynx. A second swab, with sterile water or milk will be used on the ventral and posterior surfaces of the tongue. A third swab, saturated with sterile water or human milk, will be used to clean the outer surface of any dwelling oral tubes (endotracheal tube, NAVA or feeding tube). Lips will be cleaned with a sterile gauze saturated with sterile water or human milk. Oral cavity will be suctioned as needed with an oral suction devise to remove secretions.

Primary outcomes

  1. Number of participants with oral microbiome dysbiosis.

    Time frame: 0-28 days

    Oral samples will be obtained weekly and the microbiome analyzed using rRNA 16s sequencing

Secondary outcomes

  1. Number of participants with ventilator associated pneumonia

    Time frame: 0-28 days

    Evidence of ventilator pneumonia will be assessed weekly over the first 4 weeks of life

  2. Number of participants with bronchopulmonary dysplasia

    Time frame: 0-60 days

    Evidence of bronchopulmonary dysplasia will be assessed weekly over the first 60 days of life

  3. Number of days requiring respiratory support

    Time frame: 0-60 days

    Days the infant was on any type of respiratory support will be assessed daily for the first 60 days of life

Study contacts

Contact information is provided by the study sponsor or research team.

Leslie A Parker, PhD, APRN

CONTACT

[email protected]

352-273-6384

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • The Gerber Foundation

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Jul 8, 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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