Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT01012505
Status:
UNKNOWN
Last Update Posted:
2009-11-13
First Post:
2009-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.
Sponsor:
Sheba Medical Center
Organization:
Study Overview
Official Title:
The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.
Status:
UNKNOWN
Status Verified Date:
2009-11
Last Known Status:
NOT_YET_RECRUITING
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:
Mammalian fetal sensory development comes in an invariant series, with the tactile/kinesthetic and chemosensory systems the earliest functioning and responsive to stimulation, implicating the importance of these foundational sensory systems for later development. Olfaction is essential for neonatal behavioral adaptation in many mammals, including humans. Experiments show that newborns recognize, and are soothed by, the smell of amniotic fluid. Provision of the mother's smell with breast pads, handkerchiefs she has worn, breast milk on a cotton ball or cotton applicator, or other means of providing odor and taste input can facilitate recognition by the infant's mother at a later time and does not appear to be detrimental to the stability of the infant.
Provision of the odor and taste of the mother's milk has been shown to facilitate the infant's mouthing, sucking, arousal, and calming from irritability, especially in preparation for oral feeding. Using 24 hour monitor analysis and cortisol saliva measurements, we will provide quantitive analysis to the effect of smell.
Provision of the odor and taste of the mother's milk has been shown to facilitate the infant's mouthing, sucking, arousal, and calming from irritability, especially in preparation for oral feeding. Using 24 hour monitor analysis and cortisol saliva measurements, we will provide quantitive analysis to the effect of smell.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: