Neuroendocrine Mechanisms of Developmental Massage Therap... | NCT00722943

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

NCT00722943

Sponsor

University of Utah

Status

Completed

Last Update Posted

Feb 8, 2013Estimated

Enrollment

46Actual

Phase

Not Applicable

Conditions

Premature Birth of Newborn

Interventions

Developmental Massage Therapy
no intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Jul 24, 2008

First Submission Date that Met QC Criteria

Jul 24, 2008

First Posted Date

Jul 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2013

Last Update Posted Date

Feb 8, 2013Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Developmental Massage Therapy	Other	Tactile stimulation and massage will be done by a licensed therapist	DMT group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Growth		Weekly

Secondary Outcomes

Measure	Description	Time Frame
Salivary cortisol levels		Daily for first week; Weekly thereafter
Neurobehavioral Assessment		Weekly, Term, 3 months, 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

14 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laurie J Moyer-Mileur, PhD	University of Utah	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intermountain Medical Center		Murray	Utah	84107	United States
St. Mark's Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23062248	Derived	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.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D047928	Premature Birth
D015430	Weight Gain