Cue-based Tactile Stimulation and Infant Stress Reactivity
This study is currently recruiting participants.
Verified May 2010 by Penn State University
Sponsor:
Penn State University
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT01121523
First received: May 10, 2010
Last updated: May 11, 2010
Last verified: May 2010
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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:
- 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.
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
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 May 23, 2013