Cue-based Tactile Stimulation and Infant Stress Reactivity
NCT ID: NCT01121523
Last Updated: 2015-10-21
Study Results
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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COMPLETED
NA
56 participants
INTERVENTIONAL
2010-01-31
2013-12-31
Brief Summary
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Detailed Description
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1. To evaluate the short-term effects of infant massage intervention on infant and maternal stress reactivity from assays of maternal and infant salivary cortisol, and cortisol levels in mothers' breast milk.
2. To examine the impact of mother-delivered infant massage on the development of infant resistance to infectious pathogens and antibody-based protective immunity in response to routine scheduled vaccinations, and to examine if the degree of immunity is mediated by infant stress reactivity.
3. To examine the impact of mother-delivered infant massage, and of changes in stress reactivity in response to massage, on infant physiological functioning (vagal tone, heart rate variability), infant physical development (weight, height, and head circumference), mothers' perception of infant temperament and infant state regulation, parenting self-efficacy, symptoms of depression and anxiety, and mother-infant interaction.
4. To examine associations between cortisol levels in mothers' saliva, mothers' breast milk, and infants' saliva. Establishing such linkages would support recent animal data suggesting that infant glucocorticoid levels can be affected by glucocorticoid levels transferred to the infant in mother's milk.
5. To examine whether a single nucleotide polymorphism (SNP) in three candidate genes (Mu opioid receptor, brain-derived neurotropic factor, and vasopressin V1b receptor), each associated with hypothalamic-pituitary-adrenal axis (HPA) functioning, moderates the effects of infant massage on stress-related outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Cue-directed tactile stimulation
Cue directed tactile stimulation
Cue-based tactile stimulation delivered to medically stable premature infants three times daily by mothers or trained NICU nurses daily for 4 consecutive weeks
Control group
Cue directed tactile stimulation
Cue-based tactile stimulation delivered to medically stable premature infants three times daily by mothers or trained NICU nurses daily for 4 consecutive weeks
Interventions
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Cue directed tactile stimulation
Cue-based tactile stimulation delivered to medically stable premature infants three times daily by mothers or trained NICU nurses daily for 4 consecutive weeks
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* With any chromosomal abnormality
* With congenital heart disease
* With any surgical intervention
* With intraventricular hemorrhages greater than grade II
* If mother dies during delivery
7 Days
4 Months
ALL
Yes
Sponsors
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Penn State University
OTHER
Responsible Party
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Douglas M. Teti
Professor of Human Development
Principal Investigators
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Douglas M Teti, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Pennsylvania State University
Locations
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Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
Countries
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Other Identifiers
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Project Touch
Identifier Type: -
Identifier Source: org_study_id
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