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Completed

NCT Number: NCT00722943

Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study

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.

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Key information

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intermountain Medical Center, Murray, Utah, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Developmental Massage Therapy

Other

Tactile stimulation and massage will be done by a licensed therapist

No intervention

Other

The infant will not be touched by the therapist.

Primary outcomes

  1. Growth

    Time frame: Weekly

Secondary outcomes

  1. Salivary cortisol levels

    Time frame: Daily for first week; Weekly thereafter

  2. Neurobehavioral Assessment

    Time frame: Weekly, Term, 3 months, 6 months

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: DMT

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 28, 2008
Registry last updated
Feb 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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