NCT01012505

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
Last Updated

November 13, 2009

Status Verified

November 1, 2009

First QC Date

November 11, 2009

Last Update Submit

November 12, 2009

Conditions

Study Arms (1)

20 preterm infants

20 preterm infants without active disease

Other: adding pad with maternal milk in hte incubator

Interventions

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

20 preterm infants

Eligibility Criteria

Age7 Days - 4 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

preterm infants at least 1 weekk of age no active disease or treatment (like respiratory support) place in incubator

You may qualify if:

  • preterm infants at least 1 week of age
  • no active disease or treatment (like respiratory support)
  • place in incubator

You may not qualify if:

  • active disease or treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Ramat Gan, 52621, Israel

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 11, 2009

First Posted

November 13, 2009

Study Start

December 1, 2009

Last Updated

November 13, 2009

Record last verified: 2009-11

Locations