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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00722943
Other study ID # 28032
Secondary ID
Status Completed
Phase N/A
First received July 24, 2008
Last updated February 6, 2013
Start date July 2008
Est. completion date July 2011

Study information

Verified date February 2013
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to see if daily massage therapy will help premature infants respond to stress better, as well as improve their growth and neurobehavioral development.


Description:

Optimal postnatal growth and development is essential for the survival and long-term health of infants born premature, however, growth and developmental delays are common. Many factors contribute to poor postnatal growth and development including immature organ systems, stress due to illness and even routine care in the neonatal intensive care unit environment. Massage therapy is associated with decreased cortisol levels during stress in a variety of populations including premature infants. Massage has also been reported to improve postnatal weight gain in premature infants. Concerns about methodological quality, however, weaken the credibility of previous studies and prevent the integration of massage therapy into conventional medical practice. Therefore, we plan to study the interrelationship of the ANS and HPA axis in preterm infants to assess how developmental massage therapy (DMT) modulates physiologic stability and promotes postnatal growth by the following specific aims:

SPECIFIC AIM 1: We will determine ANS balance, measured by heart period variability, before, during, and after DMT.

SPECIFIC AIM 2: We will compare the relationships between ANS balance and HPA response before and after DMT.

SPECIFIC AIM 3: We will evaluate somatotrophic response in premature infants who receive DMT.

Infants will be stratified by gender and randomized to receive developmental massage therapy or SHAM control.

This study will also allow for post-discharge assessment of development. Infants will return to the hospital at term, 3months and 6 months for multiple measurements and developmental testing.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 14 Days
Eligibility Inclusion Criteria:

- Premature infants born between 29 4/7 and 32 3/7 weeks gestation by physical exam at birth, and with birth weight, length and head circumference between the 5th and 95th percentiles for gestational age.

Exclusion Criteria:

- Intrauterine growth less than the 5th or greater than the 95th percentiles for gestational age, congenital anomalies, complex cardiac defects, severe CNS injury, hypothyroidism, inborn errors of metabolism, or inability to establish full enteral feeds by day of life 14.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Developmental Massage Therapy
Tactile stimulation and massage will be done by a licensed therapist
no intervention
The infant will not be touched by the therapist.

Locations

Country Name City State
United States Intermountain Medical Center Murray Utah
United States St. Mark's Hospital Salt Lake City Utah
United States University of Utah Salt Lake City Utah

Sponsors (2)

Lead Sponsor Collaborator
University of Utah National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Growth Weekly No
Secondary Salivary cortisol levels Daily for first week; Weekly thereafter No
Secondary Neurobehavioral Assessment Weekly, Term, 3 months, 6 months No
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