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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Number of participants with oral microbiome dysbiosis. [Срок оценки: 0-28 days]

Вторичные конечные точки (3)

• Number of participants with ventilator associated pneumonia [Срок оценки: 0-28 days]
• Number of participants with bronchopulmonary dysplasia [Срок оценки: 0-60 days]
• Number of days requiring respiratory support [Срок оценки: 0-60 days]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

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

Идентификаторы

NCT: NCT06000761 · 202101340

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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