Cue-based Tactile Stimulation and Infant Stress Reactivity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Penn State University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT01121523
First received: May 10, 2010
Last updated: May 11, 2010
Last verified: May 2010
  Purpose

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
Infant, Premature
Behavioral: Cue directed tactile stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    Infant and maternal salivary cortisol


Secondary Outcome Measures:
  • Infant immune functioning [ Time Frame: 2-3 months post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated 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.
  Eligibility

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121523

Locations
United States, Pennsylvania
Penn State Hershey Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Jennifer Stokes, RN    717-531-7765    jstokes1@hmc.psu.edu   
Contact: Sarah Sturgis, MSN    (717 )531-7762    ssturgis@hmc.psu.edu   
Sub-Investigator: Charles Palmer, MB CHB         
Sub-Investigator: Robert Bonneau, Ph.D.         
Sub-Investigator: Kimberly Haidet, Ph.D.         
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Douglas M Teti, Ph.D. The Pennsylvania State University
  More Information

No publications provided

Responsible Party: Douglas M. Teti, The Pennsylvania State University
ClinicalTrials.gov Identifier: NCT01121523     History of Changes
Other Study ID Numbers: Project Touch
Study First Received: May 10, 2010
Last Updated: May 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Prematurity
massage
stress
immune functioning
parenting

ClinicalTrials.gov processed this record on August 28, 2014