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Cue-based Tactile Stimulation and Infant Stress Reactivity

Primary Purpose

Premature; Infant, Light-for-dates

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cue directed tactile stimulation
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature; Infant, Light-for-dates focused on measuring Prematurity, massage, stress, parenting, infancy, sleep, intervention

Eligibility Criteria

7 Days - 4 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Penn State Hershey Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cue-directed tactile stimulation

Control group

Arm Description

Outcomes

Primary Outcome Measures

Stress reactivity
Infant and maternal salivary cortisol

Secondary Outcome Measures

Infant immune functioning

Full Information

First Posted
May 10, 2010
Last Updated
October 19, 2015
Sponsor
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT01121523
Brief Title
Cue-based Tactile Stimulation and Infant Stress Reactivity
Official Title
Effect of Cue-based Tactile Stimulation on Premature, Low Birth Weight Infants: Stress Reactivity.Immune Functioning, and Parenting
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature; Infant, Light-for-dates
Keywords
Prematurity, massage, stress, parenting, infancy, sleep, intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cue-directed tactile stimulation
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cue directed tactile stimulation
Other Intervention Name(s)
Massage
Intervention Description
Cue-based tactile stimulation delivered to medically stable premature infants three times daily by mothers or trained NICU nurses daily for 4 consecutive weeks
Primary Outcome Measure Information:
Title
Stress reactivity
Description
Infant and maternal salivary cortisol
Time Frame
one month post-intervention
Secondary Outcome Measure Information:
Title
Infant immune functioning
Time Frame
2-3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas M Teti, Ph.D.
Organizational Affiliation
The Pennsylvania State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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Cue-based Tactile Stimulation and Infant Stress Reactivity

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