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NCT00029198 · ClinicalTrials.gov registry record · Phase 3
Preterm Infants' Weight Gain Following Massage Therapy
A Phase 3 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 3
- Development phase
- 139
- Enrollment target
NCT00029198 is a Phase 3 study that has completed, run by University of Miami. The registered enrollment target is 139 participants.
The verdict
NCT00029198, a Phase 3 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 139 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE massage
- PROCEDURE Sham massage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2003-04 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00029198
The ClinicalTrials.gov registry entry for NCT00029198 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which massage is the first listed.
NCT00029198 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00029198 about?
NCT00029198 is a clinical study titled "Preterm Infants' Weight Gain Following Massage Therapy". 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 o...
What is the current status of trial NCT00029198?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 139 participants. The study started on 2003-04. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00029198?
The interventions under investigation include: massage (PROCEDURE), Sham massage (PROCEDURE).
Who is sponsoring clinical trial NCT00029198?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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