Clinical trial NCT01121523: 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
Overall status: COMPLETED
Phase: NA
Conditions: Premature; Infant, Light-for-dates
Keywords: Prematurity
massage
stress
parenting
infancy
sleep
intervention
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2010-05-12
Enrollment: 56
Sex: ALL
Minimum age (years): 7
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Stress reactivity
timeFrame: one month post-intervention
Secondary outcomes:
measure: Infant immune functioning
timeFrame: 2-3 months post-intervention
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Children's Hospital
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Douglas M Teti, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: