Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569641
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective non-randomized longitudinal design of 30-40 infants from initiation of oral feeding until discharge to track feeding changes as a potential indicator of surgical recovery
Detailed Description:
Safe oral feeding is a challenge for infants born with complex congenital heart disease CHD These infants are likely to require tube-assisted feeding at the initiation of enteral feeding and struggle to transition to full oral feeding Infant post-surgery recovery includes a safe transition to oral feeding without respiratory risk Neoneur Feeding System consists of a novel hand-held mobile phone application and a cloud based computation which innovatively measures patterns of oral cavity pressure synchronized with respiration providing a quantitative assessment of feeding patterns Yet there has been no quantitative means of measuring this recovery process The concept of post-surgical recovery model is not new The adult literature is replete with physiologic and behavioral indicators of recovery More recently Roy and colleagues introduced a recovery model for post-surgical CHD children to adults using a component metrics of physiologic parameters We are proposing to develop an infant specific recovery model using feeding patterns using data generated by the Neoneur device The model using the lens of behavioral organization will include feeding measurements from initiation of oral feeding to discharge
This study will evaluate the association between feeding recovery and clinical assessment of infant behaviors as measured in a brief survey to assess irritability ability to be soothed alertness non-nutritive sucking and muscle tone Forty infants will be recruited from the PCICU-CSD at MUSC to capture thirty usable infant sets of Neoneur data from the PCICU-CSD at MUSC This data will be assessed using the Neoneur Feeding System to create a model of feeding recovery
This study will evaluate the association between feeding recovery and clinical assessment of infant behaviors as measured in a brief survey to assess irritability ability to be soothed alertness non-nutritive sucking and muscle tone Forty infants will be recruited from the PCICU-CSD at MUSC to capture thirty usable infant sets of Neoneur data from the PCICU-CSD at MUSC This data will be assessed using the Neoneur Feeding System to create a model of feeding recovery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None