Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00029198
Status:
COMPLETED
Last Update Posted:
2014-04-10
First Post:
2002-01-09
Brief Title:
Preterm Infants Weight Gain Following Massage Therapy
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Preterm Infants Weight Gain Following Massage Therapy
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 therapyweight gain relationship is a critical process required by the neonatology community for massage therapy to be adopted as a standard neonatal intensive care unit
Detailed Description:
A number of studies have documented an average of 47 greater weight gain in preterm neonates following massage therapy Our currently funded study suggests that massage therapy increases vagal activity oxytocin and IGF-1 In the proposed continuation of this study preemies would be provided daily massages three times a day for 10 days as in our previously successful protocol To determine potential mechanisms that may underlie the massage therapyweight gain relationship we will continue to assess vagal activity and assay insulin oxytocin IGF-1 and cortisol as well as gastric motility We have added an alternative potential pathway for the massage therapyweight gain relationship In this expanded model activity level and the related measures of heart rate oxygen consumption based on a formula calculated from heart rate and temperature mediate the effects of massage therapy on weight gain A larger sample will be recruited so that we can have the power needed to test our model of the potential mechanisms underlying the weight gain from preterm infant massage For the current application 120 preterm infants with common medical complications of prematurity who are medically stable and residing in the intermediate care grower nursery will be assigned to groups based on a random stratification on the following variables gender gestational age birthweight days in the NICU and study entry weight One hundred twenty infants will be randomly assigned to one of two groups 1 ten days of massage therapy n60 or 2 standard treatment n60 Within-subjects and between-groups analyses will focus on physiological heart rate vagal tone gastric motility and temperature biochemical insulin oxytocin IGF-1 and cortisol and behavioral variables activity level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AT000370 | NIH | None | httpsreporternihgovquickSearchR01AT000370 |
| R01AT000370-01 | NIH | None | None |