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Cue-based Tactile Stimulation and Infant Stress Reactivity

This study has been completed.
Information provided by (Responsible Party):
Douglas M. Teti, Penn State University Identifier:
First received: May 10, 2010
Last updated: October 19, 2015
Last verified: October 2015
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.

Condition Intervention
Premature; Infant, Light-for-dates
Behavioral: Cue directed tactile stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Cue-based Tactile Stimulation on Premature, Low Birth Weight Infants: Stress Reactivity.Immune Functioning, and Parenting

Resource links provided by NLM:

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Stress reactivity [ Time Frame: one month post-intervention ]
    Infant and maternal salivary cortisol

Secondary Outcome Measures:
  • Infant immune functioning [ Time Frame: 2-3 months post-intervention ]

Enrollment: 56
Study Start Date: January 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cue-directed tactile stimulation Behavioral: 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 Name: Massage
Active Comparator: Control group Behavioral: 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 Name: Massage

Detailed 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.

Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01121523

United States, Pennsylvania
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Principal Investigator: Douglas M Teti, Ph.D. The Pennsylvania State University
  More Information

Responsible Party: Douglas M. Teti, Professor of Human Development, Penn State University Identifier: NCT01121523     History of Changes
Other Study ID Numbers: Project Touch
Study First Received: May 10, 2010
Last Updated: October 19, 2015

Keywords provided by Penn State University:

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications processed this record on May 23, 2017