Cue-based Tactile Stimulation and Infant Stress Reactivity

Not Applicable

Completed

• Conditions: Premature; Infant, Light-for-dates
• Interventions: Behavioral: Cue directed tactile stimulation

• Registration Number: NCT01121523
• Lead Sponsor: Penn State University

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:

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Cue directed tactile stimulation	-
Cue-directed tactile stimulation	Cue directed tactile stimulation	-

Primary Outcome Measures

Name	Time	Method
Stress reactivity	one month post-intervention	Infant and maternal salivary cortisol

Secondary Outcome Measures

Name	Time	Method
Infant immune functioning	2-3 months post-intervention

Trial Locations

Locations (1)

Penn State Hershey Children's Hospital; 🇺🇸 Hershey, Pennsylvania, United States