Effect of Cue-based Tactile Stimulation on Premature, Low Birth Weight Infants: Stress Reactivity.Immune Functioning, and Parenting
| City: |
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Hershey |
| State: |
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Pennsylvania |
| Zip Code: |
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17033 |
| Conditions: |
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Infant, Premature |
| Purpose: |
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The present study is an examination of cue-directed tactile stimulation (CTDS), administered
by mothers and NICU nurses, on infant and maternal stress reactivity, infant immune system
functioning, maternal parenting cognitions, and parenting competence.
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| Study Summary: |
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The overarching aim of this study is to assess the effects of a program of mother-delivered,
cue-based infant massage on stress reactivity in the mother-infant dyad, and on other
measures of mother-infant functioning. The study has several interrelated objectives:
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.
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| Criteria: |
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Exclusion Criteria:
- The following babies will be excluded:
- With any chromosomal abnormality
- With congenital heart disease
- With any surgical intervention
- With intraventricular hemorrhages greater than grade II
- If mother dies during delivery
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| NCT ID: |
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NCT01121523 |
| Primary Contact: |
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Principal Investigator
Douglas M Teti, Ph.D.
The Pennsylvania State University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Hershey, Pennsylvania 17033
United States
Jennifer Stokes, RN
Phone: 717-531-7765
Email: jstokes1@hmc.psu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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