Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standardized oral Care.
- Who it may be relevant to
- Registry conditions: Ventilator Associated Pneumonia, Bronchopulmonary Dysplasia, Respiratory Disease. Basic parameters: 1 Hour — 3 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
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.
Interventions
- Procedure Standardized oral Care
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). L
Primary outcome measures
- Number of participants with oral microbiome dysbiosis. [Time frame: 0-28 days]
Secondary outcome measures (3)
- Number of participants with ventilator associated pneumonia [Time frame: 0-28 days]
- Number of participants with bronchopulmonary dysplasia [Time frame: 0-60 days]
- Number of days requiring respiratory support [Time frame: 0-60 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida — Gainesville
Identifiers
NCT: NCT06000761 · 202101340