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

ConditionsVentilator Associated PneumoniaBronchopulmonary DysplasiaRespiratory Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Mother ≥18 years of age

≤ 30 weeks gestation

Born weighing ≤ 1500 grams

Congenital anomalies of the face, lungs, or gastrointestinal system

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • Standardized oral Care

    Procedure/Surgery

    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.

Treatment groups

218 Participants
are divided into 3 treatment groups
Group A: Group 1Active comparator 1 intervention
Group B: Group 2Active comparator 1 intervention
Group C: Group 3Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with oral microbiome dysbiosis.

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

Time frame
0-28 days

Secondary outcomes

1

Number of participants with ventilator associated pneumonia

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

Time frame
0-28 days
2

Number of participants with bronchopulmonary dysplasia

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

Time frame
0-60 days
3

Number of days requiring respiratory support

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

Time frame
0-60 days

Other outcomes

Sponsors and contacts

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University of Florida

Lead sponsor

The Gerber Foundation

Collaborator

Source ClinicalTrials.gov
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