Preterm Infants' Weight Gain Following Massage Therapy
Completed · Phase 3 · Has a placebo group
Conditions studied: Premature Birth
In brief
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.
Key facts
- Study ID
- NCT00029198
- Run by
- University of Miami
- People needed
- 139
- Starts
- 2003-04-01
- Expected to finish
- 2008-03-01
- Last updated by the study team
- 2014-04-10
Who can join
Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- University of Miami School of Medicine — Miami, Florida, United States
Full record on ClinicalTrials.gov
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