Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06000761
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-08-14
Brief Title:
Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None