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NCT00317278 · ClinicalTrials.gov registry record · Phase 1
Effects of Massage on the Immune System of Preterm Infants
A Phase 1 study, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT00317278 is a Phase 1 study that has completed, run by National Center for Complementary and Integrative Health (NCCIH). The registered enrollment target is 120 participants.
The verdict
NCT00317278, a Phase 1 study, has completed, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
Infants in the Neonatal Intensive Care Unit (NICU) are exposed to stressful stimuli such as loud noises, bright lights, blood drawing, suctioning, and intubation, and are frequently left in isolation with minimal proper interaction. Stress has been demonstrated to exert a negative effect on the immune system. Different psychological interventions, including relaxation, have been used in efforts to reduce stress, and several of these techniques have been shown to improve cellular immunity. Massage therapy (MT) has been used to reduce stress in premature infants and has been associated with weight gain, shorter hospital stay, and improvement in mental/motor development. While MT has been shown to increase the number and function of natural killer (NK) cells in healthy adults and in adults infected with HIV, the effect of MT on the immune system of children, including premature infants, has never been investigated. The investigators hypothesize that, in premature infants, MT will enhance the immune system. One hundred and twenty stable premature infants meeting selection criteria will be randomized to massage and sham treatment groups. Immunologic evaluation will be performed on both groups at baseline, midway and at the end of therapy. Physicians, nurses, and parents will be masked. The investigators' unique and innovative study will be the largest study in this area and will provide valuable information on potential immune parameters associated with stress reduction and improved development in premature infants undergoing massage therapy.
Interventions
- OTHER Sham
- OTHER massage therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2005-10 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00317278
The ClinicalTrials.gov registry entry for NCT00317278 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Center for Complementary and Integrative Health (NCCIH), which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT00317278 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00317278 about?
NCT00317278 is a clinical study titled "Effects of Massage on the Immune System of Preterm Infants". Infants in the Neonatal Intensive Care Unit (NICU) are exposed to stressful stimuli such as loud noises, bright lights, blood drawing, suctioning, and intubation, and are frequently left in isolation with minimal proper interaction. Stress has been demonstrated to exert a negative effect on the immu...
What is the current status of trial NCT00317278?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2005-10. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00317278?
The interventions under investigation include: Sham (OTHER), massage therapy (OTHER).
Who is sponsoring clinical trial NCT00317278?
This trial is sponsored by National Center for Complementary and Integrative Health (NCCIH), which has 203 total clinical trials registered on ClinicalTrials.gov.
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