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Cue-based Tactile Stimulation and Infant Stress Reactivity

The Pennsylvania State University (PENNSTATE) logo

The Pennsylvania State University (PENNSTATE)

Status

Completed

Conditions

Premature; Infant, Light-for-dates

Treatments

Behavioral: Cue directed tactile stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01121523
Project Touch

Details and patient eligibility

About

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.

Full description

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.

Enrollment

56 patients

Sex

All

Ages

7 days to 4 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

56 participants in 2 patient groups

Cue-directed tactile stimulation
Experimental group
Treatment:
Behavioral: Cue directed tactile stimulation
Control group
Active Comparator group
Treatment:
Behavioral: Cue directed tactile stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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