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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Tel Aviv University
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01012505
First received: November 11, 2009
Last updated: November 12, 2009
Last verified: November 2009
  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.

Resource links provided by NLM:


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

Ages Eligible for Study:   up to 4 Weeks
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Ayala Maayan, Sheba Medical Cener
ClinicalTrials.gov Identifier: NCT01012505     History of Changes
Other Study ID Numbers: SHEBA-09-7392-AM-CTIL
Study First Received: November 11, 2009
Last Updated: November 12, 2009
Health Authority: Israel: Israeli Health Ministry Pharaceutical Adnisitration

ClinicalTrials.gov processed this record on April 23, 2014