Preterm Infants' Weight Gain Following Massage Therapy
2 other identifiers
interventional
139
1 country
1
Brief Summary
The specific aims of this study are: 1) to replicate the data that following ten days of massage therapy, preterm infants show greater daily weight gain and are discharged from the hospital earlier than the controls, thus demonstrating the cost-effectiveness of the intervention; 2) to test a model on two potential underlying mechanisms for weight gain including a) enhanced vagal activity leading to greater gastric motility, higher levels of insulin, IGF-1, and oxytocin and lower cortisol levels in the massage versus the control infants at the end of the study; and/or b) increased physical activity and its associated increase in heart rate oxygen consumption and temperature leading to greater weight gain. These pathways (vagal activity and physical activity) will be tested by path analyses. Determining underlying mechanisms for the massage therapy/weight gain relationship is a critical process required by the neonatology community for massage therapy to be adopted as a standard neonatal intensive care unit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2003
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2002
CompletedFirst Posted
Study publicly available on registry
January 10, 2002
CompletedStudy Start
First participant enrolled
April 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedApril 10, 2014
April 1, 2014
4.9 years
January 9, 2002
April 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
weight gain
post-massage
Study Arms (2)
1
EXPERIMENTAL15 minute massage tid
2
SHAM COMPARATORnon-massage touch
Interventions
Eligibility Criteria
You may qualify if:
- Gestational age between 28 and 32 weeks
- Birthweight between 800 and 1,400 grams
- Birthweight, length, and head circumference appropriate for gestational age
- Scores on the Obstetric/Postnatal Complications scales are each below 80
- NICU stay between 15 and 60 days
- Current weight between 1,000 and 1,500 grams
- Current daily intake is between 120 and 160 calories
You may not qualify if:
- Genetic anomalies, congenital heart malformations, and/or central nervous system dysfunction
- HIV infection
- History of maternal alcohol or illicit drug use
- Syphilis
- Hepatitis B
- Require surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami School of Medicine
Miami, Florida, 33136, United States
Related Publications (1)
Field T, Diego M, Hernandez-Reif M, Dieter JN, Kumar AM, Schanberg S, Kuhn C. Insulin and insulin-like growth factor-1 increased in preterm neonates following massage therapy. J Dev Behav Pediatr. 2008 Dec;29(6):463-6. doi: 10.1097/DBP.0b013e3181856d3b.
PMID: 18714203DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tiffany M Field, PhD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Touch Research Institute
Study Record Dates
First Submitted
January 9, 2002
First Posted
January 10, 2002
Study Start
April 1, 2003
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
April 10, 2014
Record last verified: 2014-04