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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01012505
Other study ID # SHEBA-09-7392-AM-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 11, 2009
Last updated November 12, 2009
Start date December 2009

Study information

Verified date November 2009
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharaceutical Adnisitration
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 4 Weeks
Eligibility Inclusion Criteria:

- preterm infants at least 1 week of age

- no active disease or treatment (like respiratory support)

- place in incubator

Exclusion Criteria:

- active disease or treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
adding pad with maternal milk in hte incubator
2 days prior to intervention - recording infants data and taking saliva cortisol adding pad with maternal milk - during 2 days - recording infants data and taking saliva cortisol. stopping intervention and for other 2 days recording infants data and taking saliva cortisol

Locations

Country Name City State
Israel Sheba medical center Ramat - Gan

Sponsors (2)

Lead Sponsor Collaborator
Sheba Medical Center Tel Aviv University

Country where clinical trial is conducted

Israel,