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The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01012505
First Posted: November 13, 2009
Last Update Posted: November 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tel Aviv University
Information provided by:
Sheba Medical Center
  Purpose

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.


Condition Intervention
Health Preterm Infants With no Active Disease Human Milk Nutrition Incubator Stay Other: adding pad with maternal milk in hte incubator

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 20
Study Start Date: December 2009
Groups/Cohorts Assigned Interventions
20 preterm infants
20 preterm infants without active disease
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


  Eligibility

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
preterm infants at least 1 weekk of age no active disease or treatment (like respiratory support) place in incubator
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012505


Locations
Israel
Sheba medical center Not yet recruiting
Ramat - Gan, Israel, 52621
Contact: Ayala Maayan-Metzger, Dr.    972-3-5302227    maayan@post.tau.ac.il   
Sponsors and Collaborators
Sheba Medical Center
Tel Aviv University
  More Information

Responsible Party: Dr. Ayala Maayan, Sheba Medical Cener
ClinicalTrials.gov Identifier: NCT01012505     History of Changes
Other Study ID Numbers: SHEBA-09-7392-AM-CTIL
First Submitted: November 11, 2009
First Posted: November 13, 2009
Last Update Posted: November 13, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications