Premature; Infant, Light-for-datesNCT01121523
Cue-based Tactile Stimulation and Infant Stress Reactivity
A study testing Cue directed tactile stimulation in people with Premature; Infant, Light-for-dates, run by Penn State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 days to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Premature; Infant, Light-for-dates
- What is being tested?
- Cue directed tactile stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17033
About this study
Official title: Effect of Cue-based Tactile Stimulation on Premature, Low Birth Weight Infants: Stress Reactivity.Immune Functioning, and Parenting
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.
Read the 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.
- Conditions
- Premature; Infant, Light-for-dates
- Being tested
- Cue directed tactile stimulation
- Keywords
- Prematurity, massage, stress, parenting, infancy, sleep, intervention
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cue directed tactile stimulationBehavioural
Also called Massage
Cue-based tactile stimulation delivered to medically stable premature infants three times daily by mothers or trained NICU nurses daily for 4 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Cue-directed tactile stimulation | Experimental | Not described Receives: Behavioral: Cue directed tactile stimulation |
| Control group | Active comparator | Not described Receives: Behavioral: Cue directed tactile stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress reactivity
Infant and maternal salivary cortisol
Measured: one month post-intervention
Secondary outcomes (1)
Infant immune functioning
Measured: 2-3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature; Infant, Light-for-datesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas M. Teti, Penn State University
- Investigators
- Douglas M Teti, Ph.D., Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121523
- Sponsor's protocol ID
- Project Touch
- Status last verified
- Oct 2015
- First submitted
- 10 May 2010
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cue-based Tactile Stimulation on Premature, Low Birth Weight Infants: Stress Reactivity.Immune Functioning, and Parenting
- ClinicalTrials.gov ID
- NCT01121523
- Acronym / sponsor ID
- Project Touch
- Conditions
- Premature; Infant, Light-for-dates
- Keywords
- Prematurity, massage, stress, parenting, infancy, sleep, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cue-directed tactile stimulation | Experimental | Behavioral: Cue directed tactile stimulation |
| Control group | Active comparator | Behavioral: Cue directed tactile stimulation |
Who may qualify
- Ages
- 7 days to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- The following babies will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cue directed tactile stimulationAlso: MassageCue-based tactile stimulation delivered to medically stable premature infants three times daily by mothers or trained NICU nurses daily for 4 consecutive weeks | Behavioural | Control group, Cue-directed tactile stimulation |
Primary outcome
Stress reactivity
Time frame: one month post-intervention
Infant and maternal salivary cortisol
1 secondary outcome
Infant immune functioning
Time frame: 2-3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
Related trials for Premature; Infant, Light-for-dates
Active, not recruiting
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition
Active, not recruiting
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
Prematurity, Light-For-Dates
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas M Teti, Ph.D. principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cue directed tactile stimulation in people with Premature; Infant, Light-for-dates, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress reactivity (time frame: one month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.