Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354517
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-29
Brief Title:
The Impact of the SENSE Program on NICU
Sponsor:
Yuksek Ihtisas University
Organization:
Yuksek Ihtisas University
Study Overview
Official Title:
The Impact of the SENSE Program on Parent and Newborn
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
The SENSE program will be applied to babies receiving treatment in the neonatal intensive care unit and the effect of the application on the baby and parents will be examined
Detailed Description:
For the growth and health of the baby the intrauterine environment provides the fetus with protective physical barriers and sensory exposures timed appropriately for its development These early exposures occur during sensory development in the intrauterine environment and there are differences in the timing of development of each sense When the baby is born prematurely the intrauterine environment is replaced by the Neonatal Intensive Care Unit environment The sensory environment of the preterm baby includes the experiences of touch movement smell sound light frequent nociceptive pain and disruption of sleep The mismatch between the infants underdeveloped coping skills and the stimulating NICU environment can cause physiological imbalance negatively impact growth and development and ultimately predispose to the development of long-term neurodevelopmental consequences Although harmful sensory exposures can negatively affect the development of the preterm baby appropriate positive sensory exposures positively affect brain development
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