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This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants who require pharmacologic therapy. We intend to evaluate acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and methodological issues. We plan to also test and generate hypotheses in preparation to apply for funding a larger randomized controlled trial.
Objectives:
Primary: To establish feasibility of a protocol for auricular acupuncture in infants suffering from NAS admitted to the NICU receiving pharmacologic therapy.
Secondary: In infants suffering from NAS admitted to the Neonatal Intensive Care Unit (NICU) receiving pharmacologic therapy:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAS babies | Experimental | Acupuncture for NAS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Acupuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Skin Breakdown and / or Cellulitis | up to 57 days | |
| Percentage of Dislodged Needles | Within three days of placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Weathers, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NAS Babies | Acupuncture for NAS Acupuncture: Acupuncture |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NAS Babies | Acupuncture for NAS Acupuncture: Acupuncture |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Skin Breakdown and / or Cellulitis | Posted | Number | participants | up to 57 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NAS Babies | Acupuncture for NAS Acupuncture |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MRI with acupuncture needle in place | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Weathers | USF Pediatrics | 813/844-3046 | lweathers@health.usf.edu |
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| ID | Term |
|---|---|
| D009357 | Neonatal Abstinence Syndrome |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| duration of nicu admission | Mean | Standard Deviation | days |
|
| duration of methadone treatment | Mean | Standard Deviation | days |
|
|
| Primary | Percentage of Dislodged Needles | Posted | Number | percentage of needles | Within three days of placement | placed needles | placed needles |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
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| D001523 | Mental Disorders |