N/A
N=21
Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies
Neonatal Abstinence Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02062151 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants With Skin Breakdown and / or Cellulitis — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Skin Breakdown and / or Cellulitis |
— | — |
| PRIMARY Percentage of Dislodged Needles |
2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Gestational age ≥37.0 wks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
- Admitted to NICU with diagnosis of NAS requiring pharmacologic therapy
- Parents give written consent within 72 hours of infant receiving first dose of methadone
Exclusion Criteria
- Helix or antihelix of ear is deformed and needle is unable to be placed
- A suspected or confirmed genetic or metabolic syndrome
- Custody retained by the Department of Children and Families
- Any skin condition involving the ear(s)
- Suspected or documented infection at the time of enrollment
Data sourced from ClinicalTrials.gov (NCT02062151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.