Cue-based Tactile Stimulation and Infant Stress Reactivity

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. 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. 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. 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. 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.

Official Title
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Effect of Cue-based Tactile Stimulation on Premature, Low Birth Weight Infants: Stress Reactivity.Immune Functioning, and Parenting

Conditions
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Premature; Infant, Light-for-dates

Intervention / Treatment
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* Behavioral: Cue directed tactile stimulation


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cue-directed tactile stimulation<br> | Behavioral: Cue directed tactile stimulation<br>* Cue-based tactile stimulation delivered to medically stable premature infants three times daily by mothers or trained NICU nurses daily for 4 consecutive weeks<br>* Other names: Massage;|
| Active Comparator: Control group<br> | Behavioral: Cue directed tactile stimulation<br>* Cue-based tactile stimulation delivered to medically stable premature infants three times daily by mothers or trained NICU nurses daily for 4 consecutive weeks<br>* Other names: Massage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress reactivity | Infant and maternal salivary cortisol | one month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant immune functioning |  | 2-3 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intervention, Prematurity, massage, stress, parenting, infancy, sleep