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

NCT ID: NCT01012505

Last Updated: 2009-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Health Preterm Infants With no Active Disease Human Milk Nutrition Incubator Stay

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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20 preterm infants

20 preterm infants without active disease

adding pad with maternal milk in hte incubator

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Days

Maximum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel Aviv University

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Cener

Locations

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Sheba medical center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Facility Contacts

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Ayala Maayan-Metzger, Dr.

Role: primary

972-3-5302227

Other Identifiers

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SHEBA-09-7392-AM-CTIL

Identifier Type: -

Identifier Source: org_study_id

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