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

NCT00722943 | Completed DMC

• 1 other identifier: 28032
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Premature Birth of Newborn

Keywords

infant; premature; message; therapy; NICU; neonatal intensive care unit; cortisol level; stress; postnatal; weight gain; DMT; Development Message Therapy; growth

Outcome Measures

Primary Outcomes (1)

• Growth

  Weekly

Secondary Outcomes (2)

• Salivary cortisol levels

  Daily for first week; Weekly thereafter

• Neurobehavioral Assessment

  Weekly, Term, 3 months, 6 months

Study Arms (2)

DMT group

ACTIVE COMPARATOR

These infants will receive tactile stimulation and developmental massage by a licensed therapist. This intervention will be done behind a screen in order to blind the therapy to NICU staff and parents.

Other: Developmental Massage Therapy

SHAM control

PLACEBO COMPARATOR

These infants will have no tactile stimulation or developmental massage done. The therapist will stand behind a screen but will not touch the infant. The screen will blind the NICU staff and parents to the study arm.

Other: no intervention

Interventions

Developmental Massage Therapy OTHER

Tactile stimulation and massage will be done by a licensed therapist

DMT group

no intervention OTHER

The infant will not be touched by the therapist.

SHAM control

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• National Institutes of Health (NIH): collaborator

Study Sites (3)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

St. Mark's Hospital

Salt Lake City, Utah, 84124, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• Moyer-Mileur LJ, Haley S, Slater H, Beachy J, Smith SL. Massage improves growth quality by decreasing body fat deposition in male preterm infants. J Pediatr. 2013 Mar;162(3):490-5. doi: 10.1016/j.jpeds.2012.08.033. Epub 2012 Oct 11.

  PMID: 23062248 DERIVED

MeSH Terms

Conditions

Premature Birth; Weight Gain

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurie J Moyer-Mileur, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 8, 2013

Record last verified: 2013-02

Locations

US (3)