Cue-based Tactile Stimulation and Infant Stress Reactivity

Premature; Infant, Light-for-dates Clinical Trial

Official title:

Effect of Cue-based Tactile Stimulation on Premature, Low Birth Weight Infants: Stress Reactivity.Immune Functioning, and Parenting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121523
• Other study ID #: Project Touch
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: October 19, 2015
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: October 2015
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 4 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth
• Premature; Infant, Light-for-dates

Intervention

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

Locations

Country	Name	City	State
United States	Penn State Hershey Children's Hospital	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress reactivity	Infant and maternal salivary cortisol	one month post-intervention	No
Secondary	Infant immune functioning		2-3 months post-intervention	No